Combination Double-Barreled and Debranching Stent Grafts and Methods for Use

ABSTRACT

A combination double-barreled and debranching stent graft and methods for its use, where the stent graft comprises, a main body stent graft defining a single lumen with distal and proximal ends, a first bifurcation in the main body defining first and second lumens, the main body stent graft defines a tubular wall that is contiguous with the first and second lumens such that any fluid entering the main body stent graft must exit by entering one of the first or second lumens, (c) a second bifurcation within the first lumen defining a first leg and a second leg, (d) a third bifurcation within the first leg defining a third leg and a fourth leg, and (e) a fourth bifurcation within the second leg between about 10 mm and about 20 mm distal from the second bifurcation defining a fifth leg and a sixth leg.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. Non-Provisionalpatent application Ser. No. 13/706,175, filed on Dec. 5, 2012 thatclaims the benefit of the filing date of U.S. Provisional PatentApplication Ser. No. 61/623,151, filed Apr. 12, 2012, U.S. ProvisionalPatent Application Ser. No. 61/646,637, filed May 14, 2012, U.S.Provisional Patent Application Ser. No. 61/716,292, filed Oct. 19, 2012,U.S. Provisional Patent Application Ser. No. 61/716,315, filed Oct. 19,2012, U.S. Provisional Patent Application Ser. No. 61/716,326, filedOct. 19, 2012, U.S. Provisional Patent Application Ser. No. 61/720,803,filed Oct. 31, 2012, U.S. Provisional Patent Application Ser. No.61/720,829, filed Oct. 31, 2012, U.S. Provisional Patent ApplicationSer. No. 61/720,846, filed Oct. 31, 2012. This application is also acontinuation of U.S. Non-Provisional patent application Ser. No.14/104,849, filed on Dec. 12, 2013 that claims the benefit of the filingdate of U.S. Provisional Patent Application Ser. No. 61/737,411, filedDec. 14, 2012. All of the foregoing applications are hereby incorporatedby reference in their entirety.

BACKGROUND OF THE INVENTION

Aneurysms occur in blood vessels in locations where, due to age, diseaseor genetic predisposition, insufficient blood vessel strength orresiliency may cause the blood vessel wall to weaken and/or lose itsshape as blood flows, resulting in a ballooning or stretching of theblood vessel at the limited strength/resiliency location, thus formingan aneurysmal sac. Left untreated, the blood vessel wall may continue toexpand to the point where the remaining strength of the blood vesselwall cannot hold and the blood vessel will fail at the aneurysmlocation, often with fatal result.

Various implantable medical devices and minimally invasive methods forimplantation of these devices have been developed to deliver thesemedical devices within the vascular system. These devices areadvantageously inserted intravascularly, typically from a deliverycatheter. In order to prevent rupture of an aneurysm, a stent graft maybe introduced into a blood vessel, deployed, and secured in a locationwithin the blood vessel such that the stent graft spans the aneurysmalsac. The outer surface of the stent graft, at its opposed ends, abutsand seals against the interior wall of the blood vessel at a locationwhere the blood vessel wall has not suffered a loss of strength orresiliency. The stent graft channels the blood flow through the hollowinterior of the stent graft, thereby reducing, if not eliminating, anystress on the blood vessel wall at the aneurysmal sac location.

In the aorta of a human or animal patient, there are a number ofimportant branch vessels which, when treating an aneurysm throughdeployment of an endovascular graft, must not be occluded. Current stentgraft systems utilize fenestrations or perforations within stent graftwalls intended to be aligned with the opening of a given branch vessel,but placement of the stent graft must be very exact and operationalalignment is often unsuccessful. When proper fenestration alignmentfails, the wall of the deployed stent graft prevents blood flow to thebranch vessel. In this case, the physician has no endovascular backupoption and must proceed with a significantly more invasive procedure.

Even when the fenestration is properly aligned with the opening of thebranch vessel, the fenestration may rotate away from the branch vessel.To prevent this rotation from occurring, a stent graft may be deployedwithin the branch vessel with one of its ends married to or joined withthe fenestration of the previously placed stent graft. The techniques tomarry another stent graft to that fenestration are often time consuming,require complicated surgical procedures and demand additional vessel orvascular access points. The marrying of two stent grafts via afenestration also has the additional problem of an inadequate seal wherethe two stent grafts are joined.

Further, current common iliac aneurysm treatments involve ligation orembolization of the internal iliac artery, frequently leading to sideeffects including, but not limited to, erectile dysfunction in men,decreased exercise tolerance, and compromise to pelvic profusion thatmay result in bowel ischemia and death.

SUMMARY OF THE INVENTION Visceral Double-Barreled Main Body Stent Graftand Methods for Use

In a first aspect, the invention provides a stent graft comprising, (a)a main body stent graft having a distal end and a proximal end, whereinthe main body stent graft has a length in the range from about 100 mm toabout 120 mm, wherein the main body stent graft has a diameter at theproximal end in the range from about 30 mm to about 45 mm, (b) a firstlumen defined at the distal end of the main body stent graft, whereinthe first lumen has a diameter in the range from about 18 mm to about 20mm, (c) a second lumen defined at the distal end of the main body stentgraft, wherein the second lumen has a diameter in the range from about16 mm to about 18 mm, wherein the first lumen and the second lumen haveabout the same length from about 50 mm to about 70 mm, wherein the firstlumen is secured to the second lumen along a shared length, and (d)wherein the main body stent graft defines a tubular wall that iscontiguous with the first lumen and the second lumen such that any fluidentering the main body must exit through one of the first lumen or thesecond lumen.

In a second aspect, the invention provides a stent graft comprising, (a)a main body stent graft having a distal end and a proximal end, whereinthe main body stent graft has a length in the range from about 100 mm toabout 120 mm, (b) a first lumen defined about 5 mm from the proximal endof the main body to the distal end of the main body, wherein the firstlumen has a substantially constant diameter along its length in therange from about 18 mm to about 20 mm, (c) a second lumen defined about5 mm from the proximal end of the main body to the distal end of themain body, wherein the second lumen has a substantially constantdiameter along its length in the range from about 16 mm to about 18 mm,wherein the first lumen is secured to the second lumen along a sharedlength.

In a third aspect, the invention provides a method for placement of astent graft according to the first or second aspects of the invention,comprising, (a) introducing a guidewire into an aorta via arterialaccess, (b) loading a delivery catheter containing a stent graftaccording to the first or second aspects of the invention onto theguidewire, (c) moving the delivery catheter along the guidewire andintroducing the delivery catheter into the aorta via arterial access,and (d) deploying the stent graft into the thoracic aorta.

In a fourth aspect, the invention provides a method for placement of astent graft according to the first or second aspects of the invention,comprising, (a) introducing a guidewire into an aortic arch via arterialaccess, (b) loading a delivery catheter containing a stent graftaccording to the first or second aspects of the invention onto theguidewire, wherein a distal end of the stent graft is loaded first, (c)moving the delivery catheter along the guidewire and introducing thedelivery catheter into the aortic arch via arterial access, and (d)deploying the stent graft into a proximal descending aorta.

In a fifth aspect, the invention provides a method for placement of astent graft according to the first or second aspects of the invention,comprising, (a) introducing a guidewire into an thoracic or abdominalaorta via arterial access, (b) loading a delivery catheter containing astent graft according to the first or second aspects of the inventiononto the guidewire, (c) moving the delivery catheter along the guidewireand introducing the delivery catheter into the thoracic or abdominalaorta via arterial access, and (d) deploying the stent graft into thethoracic or abdominal aorta.

The double-barreled stent graft and methods described with respect tothe first through the fifth aspects of the invention provide numerousbenefits. One advantage over previously known single lumen main bodystent grafts, the double-barreled stent graft can also be used as a“platform” or “anchor” that enables a surgeon to debranch visceralvessels, for example, while maintaining blood flow to the rest of thebody without putting a patient on bypass, providing a significantimprovement over prior devices and techniques. This anchoring main bodystent graft can be utilized in combination with any embodiment of thedebranching stent grafts and stent graft limbs disclosed herein or withstent graft extenders. In one non-limiting example, the double-barreledstent graft can be used for the treatment of any aneurysm of anyanatomical variation or other type of diseased aorta or traumaticinjury.

In addition, the double-barreled stent graft may be deployedtransapically, transfemorally, via the right subclavian artery, or viaany other accessible artery. When the double-barreled stent graft isdeployed in vivo, aortic flow is compartmentalized immediately, whichincreases surgical options by allowing the surgeon to engage inindividual selection of the lumens for placement of additionaldebranching stent grafts. The second lumen provides a built-in back-upsystem in case an issue arises with stent placement in the first lumen,for example. The double-barreled stent graft also minimizes surgicalimpact on the patient and leads to reduced complication rates, reducedrisk of renal failure, bowel ischemia, and heart attack and decreasedtime for patient stabilization.

Further, the contiguous nature of the walls of the double-barreled stentgraft's main body with the first and second lumens has the additionalbenefit of preventing extraneous blood flow into the aneurysm. The wallsof the double-barreled stent graft provide a complete circumferentialseal and there is no external compromise or compression of the lumenwalls, which prevents blood flow through the lumens from being affected.Previous “sandwich,” “snorkel” and “chimney” devices were constructed bysimultaneously placing two or more single lumen stent grafts side byside within the aorta. These previous stent grafts defined open spaceswhere the walls of the lumens did not completely abut each other or theaortic walls and allowed blood to flow through the open spaces and intothe aneurysm. These previous devices were further subject to collapse orcompression due to external pressures.

In addition, the cylindrical nature of walls of the double-barreledstent graft provide more positive fixation with the wall of the aortathan provided by previous devices.

Aortic Arch Double-Barreled Main Body Stent Graft and Methods for Use

In a sixth aspect, the invention provides a stent graft comprising, (a)a main body stent graft having a distal end and a proximal end, whereinthe main body stent graft has a length in the range from about 50 mm toabout 70 mm, wherein the main body stent graft has a diameter at theproximal end in the range from about 40 mm to about 60 mm, (b) a firstlumen defined at the distal end of the main body stent graft, whereinthe first lumen has a diameter in the range from about 18 mm to about 30mm, (b) a second lumen defined at the distal end of the main body stentgraft, wherein the second lumen has a diameter in the range from about18 mm to about 30 mm, (c) wherein the first lumen is secured to thesecond lumen along a shared length, wherein the shared length of thefirst lumen and the second lumen is in the range from about 30 mm toabout 65 mm, and (d) wherein the main body stent graft defines a tubularwall that is contiguous with the first lumen and the second lumen suchthat any fluid entering the main body must exit through one of the firstlumen or the second lumen.

In one embodiment of the sixth aspect of the invention, the first lumenand the second lumen are defined by a seam starting at the distal end ofthe main body stent graft and extending towards the proximal end of themain body stent graft.

In another embodiment, sixth aspect of the invention further comprises acylindrical stent graft structure coextensive with and disposed on anexterior of the main body stent graft.

In a further embodiment, the sixth aspect of the invention furthercomprises a stent valve affixed to the proximal end of the main bodystent graft, where a free end of the stent valve is covered and aportion of the stent valve extending between the free end and the mainbody stent graft is uncovered.

In a seventh aspect, the invention provides a method for placement of astent graft from the sixth aspect of the invention, comprising, (a)introducing a guidewire into an aorta via arterial access, (b) loading adelivery catheter containing a stent graft according to the sixth aspectof the invention onto the guidewire, (c) moving the delivery catheteralong the guidewire and introducing the delivery catheter into the aortavia arterial access, and (d) deploying the stent graft into the aorta.

In one embodiment, the seventh aspect further comprises (e) loading asecond delivery catheter containing a debranching stent graft accordingto the thirteenth aspect of the invention onto the guidewire, (f) movingthe second delivery catheter along the guidewire and introducing thedelivery catheter into the aorta via arterial access, and (g) deployingthe debranching stent graft into one of the aorta or a lumen of apreviously-placed stent graft, such as a stent graft according to thesixth aspect of the invention within the aorta.

In another embodiment, the seventh aspect still further comprises, (h)introducing a second guidewire into the aorta via arterial access, (i)loading a third delivery catheter containing a great vessel limbaccording to the thirteenth aspect of the invention onto the secondguidewire, (j) moving the third delivery catheter along the secondguidewire and introducing the third delivery catheter into a selectedleg of the debranching stent graft via arterial access, and (k)deploying a proximal end of the great vessel limb into the selected legof the debranching stent graft according to the thirteenth aspect of theinvention.

In an eighth aspect, the invention provides a method for placement of astent graft from the sixth aspect of the invention, comprising, (a)introducing a guidewire into an aortic arch via the femoral artery, (b)loading a delivery catheter containing a stent graft according to thesixth aspect of the invention onto the guidewire, wherein a distal endof the stent graft is loaded first, (c) moving the delivery catheteralong the guidewire and introducing the delivery catheter into theaortic arch via arterial access, and (d) deploying the stent graft intoa proximal descending aorta.

In a ninth aspect, the invention provides a method for placement of astent graft from the sixth aspect of the invention, comprising, (a)introducing a guidewire into an ascending aorta via arterial access, (b)loading a delivery catheter containing a stent graft according to thesixth aspect of the invention onto the guidewire, (c) moving thedelivery catheter along the guidewire and introducing the deliverycatheter into the ascending aorta via arterial access, and (d) deployingthe stent graft into the ascending aorta.

The double-barreled stent graft and methods described with respect tothe sixth through the ninth aspects of the invention provide numerousbenefits. One advantage over previously known single lumen main bodystent grafts, the double-barreled stent graft can also be used as a“platform” or “anchor” that enables a surgeon to debranch Great vessels,for example, while maintaining blood flow to the rest of the bodywithout putting a patient on bypass, providing a significant improvementover prior devices and techniques. This anchoring main body stent graftcan be utilized in combination with any embodiment of the debranchingstent grafts and/or stent graft limbs disclosed herein or with stentgraft extenders. In one non-limiting example, the double-barreled stentgraft can be used for the treatment of any aneurysm of any anatomicalvariation or other type of diseased aorta or traumatic injury.

In addition, the double-barreled stent graft may be deployedtransapically, transfemorally, via the right subclavian artery, or viaany other accessible artery. Unlike previously known stent grafts, thedouble-barreled stent graft can be deployed in the ascending aorta.Further, when the double-barreled stent graft is deployed in vivo,aortic flow is compartmentalized immediately, which increases surgicaloptions by allowing the surgeon to engage in individual selection of thelumens for placement of additional debranching stent grafts. The secondlumen provides a built-in back-up system in case an issue arises withstent placement in the first lumen, for example. The double-barreledstent graft also minimizes surgical impact on the patient and leads toreduced complication rates, reduced risk of renal failure, bowelischemia, and heart attack and decreased time for patient stabilization.

Further, the contiguous nature of the walls of the double-barreled stentgraft's main body with the first and second lumens has the additionalbenefit of preventing extraneous blood flow into the aneurysm. The wallsof the double-barreled stent graft provide a complete circumferentialseal and there is no external compromise or compression of the lumenwalls, which prevents blood flow through the lumens from being affected.Previous “sandwich,” “snorkel” and “chimney” devices were constructed bysimultaneously placing two or more single lumen stent grafts side byside within the aorta. These previous stent grafts defined open spaceswhere the walls of the internal lumens did not completely abut eachother or the aortic walls and allowed blood to flow through the openspaces and into the aneurysm. These previous devices were furthersubject to collapse or compression due to external pressures.

In addition, the cylindrical nature of walls of the double-barreledstent graft provide more positive fixation with the wall of the aortathan provided by previous devices.

Debranching Visceral Stent Graft and Methods for Use

In a tenth aspect, the invention provides a debranching stent graftcomprising, (a) a main body stent graft with a bifurcation defining afirst leg and a second leg, wherein the main body stent graft has adistal end and a proximal end, (b) wherein the main body stent graft hasa diameter at the proximal end in the range from about 18 mm to about 22mm, (c) wherein the first leg and the second leg each have a diameter inthe range from about 14 mm to about 16 mm, (d) wherein the distance fromthe proximal end of the main body to the distal end of the first leg isin the range from about 70 mm to about 90 mm, (e) and wherein thedistance from the proximal end of the main body to the distal end of thesecond leg is in the range from about 80 mm to about 100 mm, and whereinthe second leg is at least about 10 mm longer than the first leg.

In one embodiment of the tenth aspect of the invention, the second legis no more than about 20 mm longer than the first leg. In anotherembodiment of the tenth aspect of the invention, the bifurcation occursin the range from about 30 mm to about 40 mm from the proximal end.

In one embodiment, the tenth aspect of the invention further comprises afirst visceral limb joined with one of the first leg or the second legat the distal end of the main body stent graft. In a further embodiment,the first visceral limb has a bifurcation defining a third leg and afourth leg.

In still another embodiment, the tenth aspect of the invention furthercomprises a second visceral limb attached to the other of the first legor the second leg.

In an eleventh aspect, the invention provides a debranching stent graftcomprising, (a) a main body stent graft with a bifurcation defining afirst leg and a second leg, wherein the main body stent graft has adistal end and a proximal end, (b) wherein the main body stent graft hasa diameter at the proximal end in the range from about 28 mm to about 36mm, (c) wherein the first leg and the second leg each have a diameter ofabout 14 mm, (d) wherein the distance from the proximal end of the mainbody to the distal end of the first leg is about 70 mm, (e) and whereinthe distance from the proximal end of the main body to the distal end ofthe second leg is about 80 mm.

In one embodiment, the eleventh aspect further comprises a visceral limbattached to the first leg at the distal end of the main body stentgraft, wherein the first visceral limb has a bifurcation defining athird leg and a fourth leg, wherein the bifurcation occurs immediatelyat the proximal end of the first visceral limb, wherein the firstvisceral limb has a length of about 30 mm, and wherein each of the thirdleg and the fourth leg have a diameter of about 7 mm.

In one embodiment, the eleventh aspect further comprises, a visceralextension joined with the second leg, wherein the visceral extension hasa proximal end and a distal end, wherein the visceral extensioncomprises a tubular main leg with a bifurcation defining a firstextension leg and a second extension leg, wherein the first extensionleg has a distal diameter of about 7 mm and the second extension leg hasa distal diameter of about 16 mm, and wherein the visceral extension hasa diameter of about 15 mm at the proximal end and a diameter of about 20mm at the bifurcation, wherein the visceral extension has a length ofabout 93 mm.

In a twelfth aspect, the invention provides a method for placement of adebranching stent graft according to the tenth or eleventh aspect of theinvention, comprising (a) introducing a guidewire into an aorta viaarterial access, (b) loading a delivery catheter containing adebranching stent graft according to the tenth or eleventh aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the aorta viaarterial access, (d) and deploying the debranching stent graft into oneof the aorta or a lumen of a previously-placed stent graft, such as astent graft according to the first or second aspects of the inventionwithin the aorta.

In one embodiment, the twelfth aspect further comprises, (e) introducinga second guidewire into the aorta via arterial access, (f) loading asecond delivery catheter containing a visceral limb stent graftaccording to the tenth or eleventh aspect of the invention onto thesecond guidewire, (g) moving the second delivery catheter along thesecond guidewire and introducing the second delivery catheter into aselected leg of the debranching stent graft according to the tenth oreleventh aspect of the invention via arterial access, and (h) deployinga proximal end of the visceral limb stent graft into the selected leg ofthe debranching stent graft according to the tenth or eleventh aspect ofthe invention.

In another embodiment, the twelfth aspect further comprises, (i)introducing a third guidewire into the aorta via arterial access andinto a selected lumen of the debranching stent graft according to thetenth or eleventh aspect of the invention, (j) loading a third deliverycatheter containing a visceral extension stent graft according to thetenth or eleventh aspect of the invention onto the third guidewire, (k)moving the third delivery catheter along the third guidewire andintroducing the third delivery catheter into the selected lumen of thedebranching stent graft via arterial access, and (1) deploying aproximal end of the visceral extension stent graft into the selectedlumen of the debranching stent graft, while the distal end extends intoa native vessel.

The debranching stent graft and methods described with respect to thetenth through the twelfth aspects of the invention provide numerousbenefits. For example, the debranching stent graft can be used incombination with any embodiment of the double-barreled stent graft orstent graft limb disclosed herein, or other main body anchoring stentgraft, for treatment of any aneurysm of any anatomical variation orother type of diseased aorta or traumatic injury. The debranching stentgraft also beneficially adds another level of debranching, from onelevel to two, via the first and second legs. In addition, a furtherlevel of debranching, from two levels to four, can be obtained dependingon the visceral limb(s) selected for use in certain embodiments.Further, the modular nature of the visceral limbs, in some embodiments,provides versatility for stent selection and provides built-in back-upsystems so the surgeon can diverge from the planned treatment plan.These capabilities ensure that blood flow to end organs is maintainedduring the entire procedure.

Further, the debranching stent graft allows for a top-down debranchingapproach, which can be advantageous depending on the desired vessellocation for placement of the stent-graft. One non-limiting example isto use an arm approach when stenting the visceral arteries. The armapproach provides an optimal angle of attack, whether there is a normalor tortuous path to reach the vessel, to extend a guidewire through aleg of the debranching stent graft and into the visceral arteries inorder to place an extension stent graft from the top-down. This approachmoves the stent graft and guidewire with the natural direction of bloodflow ensuring natural laminar flow.

Debranching Great Vessel Stent Graft and Methods for Use

In a thirteenth aspect, the invention provides a debranching stent graftcomprising, (a) a main body stent graft with a first bifurcationdefining a first leg and a second leg, wherein the main body stent grafthas a distal end and a proximal end, wherein the main body stent grafthas a diameter at the proximal end in the range from about 18 mm toabout 28 mm, (b) wherein the first leg and the second leg each have adiameter in the range from about 12 mm to about 18 mm, (c) wherein thedistance from the proximal end of the main body to the distal end of thefirst leg is in the range from about 30 mm to about 50 mm, and (d)wherein the distance from the proximal end of the main body to thedistal end of the second leg is in a range from about 50 mm to about 70mm.

In one embodiment of the thirteenth aspect of the invention, the firstbifurcation occurs in the range from about 20 mm to about 45 mm from theproximal end.

In another embodiment, the thirteenth aspect of the invention furthercomprises a first great vessel limb joined with one of the first leg orthe second leg at the distal end of the main body stent graft. In afurther embodiment, the first great vessel limb has a bifurcationdefining a third leg and a fourth leg.

In still another embodiment, the thirteenth aspect of the inventionfurther comprises a second visceral limb attached to the other of thefirst leg or the second leg.

In a further embodiment, the second visceral limb comprises an extensionstent graft.

In a fourteenth aspect, the invention provides a method for placement ofa debranching stent graft according to the thirteenth aspect of theinvention, comprising (a) introducing a guidewire into an aorta viaarterial access, (b) loading a delivery catheter containing adebranching stent graft according to the thirteenth aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the aorta viaarterial access, and (d) deploying the debranching stent graft into oneof the aorta or a lumen of a previously-placed stent graft, such as astent graft according to the sixth aspect of the invention within theaorta.

In one embodiment, the fourteenth aspect further comprises, (e)introducing a second guidewire into the aorta via arterial access, (f)loading a second delivery catheter containing a great vessel limbaccording to the thirteenth aspect of the invention onto the secondguidewire, (g) moving the second delivery catheter along the secondguidewire and introducing the second delivery catheter into a selectedleg of the debranching stent graft via arterial access, and (h)deploying a proximal end of the great vessel limb into the selected legof the debranching stent graft.

In one embodiment, the fourteenth aspect still further comprises, (i)introducing a third guidewire into the aorta via arterial access andinto a selected lumen of the debranching stent graft, (j) loading athird delivery catheter containing an extension stent graft according tothe thirteenth aspect of the invention onto the third guidewire, (k)moving the third delivery catheter along the third guidewire andintroducing the third delivery catheter into the selected lumen of thedebranching stent graft via arterial access, and (1) deploying aproximal end of the extension stent graft into the selected lumen of thedebranching stent graft, while the distal end of the extension stentgraft extends into a vessel.

In a fifteenth aspect, the invention provides a method for placement ofa debranching stent graft according to the thirteenth aspect of theinvention, comprising (a) introducing a guidewire into an aortic archvia arterial access, (b) loading a delivery catheter containing adebranching stent graft according to the thirteenth aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the aortic arch viaarterial access, and (d) deploying the debranching stent graft into oneof the proximal descending aorta or a lumen of a previously-placed stentgraft, such as a stent graft according to the sixth aspect of theinvention within the proximal descending aorta.

In a sixteenth aspect, the invention provides a method for placement ofa debranching stent graft according to the thirteenth aspect of theinvention, comprising (a) introducing a guidewire into an ascendingaorta via arterial access, (b) loading a delivery catheter containing adebranching stent graft according to the thirteenth aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the ascending aortavia arterial access, and (d) deploying the debranching stent graft intoone of the ascending aorta or a lumen of a previously-placed stentgraft, such as a stent graft according to the sixth aspect of theinvention within the ascending aorta.

In one embodiment, the sixteenth aspect further comprises, (e)introducing a second guidewire into the ascending aorta via arterialaccess and into a selected leg of the debranching stent graft accordingto the thirteenth aspect of the invention, (f) loading a second deliverycatheter containing a great vessel limb according to the thirteenthaspect of the invention onto the second guidewire, (g) moving the seconddelivery catheter along the second guidewire and introducing the seconddelivery catheter into the selected leg of the debranching stent graftvia arterial access, and (h) deploying a proximal end of the greatvessel limb according to the thirteenth aspect of the invention into theselected leg of the debranching stent graft.

In one embodiment, the sixteenth aspect still further comprises, (i)introducing a third guidewire into the ascending aorta via arterialaccess and into a selected leg of the debranching stent graft, (j)loading a third delivery catheter containing an extension stent graftaccording to the thirteenth aspect of the invention onto the thirdguidewire, (k) moving the third delivery catheter along the thirdguidewire and introducing the third delivery catheter into the selectedleg of the debranching stent graft via arterial access, and (1)deploying a proximal end of the extension stent graft into the selectedleg of the debranching stent graft, while the distal end of theextension stent graft extends into a great vessel.

The debranching stent graft and methods described with respect to thethirteenth through the sixteenth aspects of the invention providenumerous benefits. For example, the debranching stent graft can be usedin combination with any embodiment of the double-barreled stent graft orstent graft limb disclosed herein, or other main body anchoring stentgraft, for treatment of any aneurysm of any anatomical variation orother type of diseased aorta or traumatic injury. The debranching stentgraft also beneficially adds another level of debranching, from onelevel to two, via the first and second legs. In addition, a furtherlevel of debranching, from two levels to four, can be obtained dependingon the Great vessel limb(s) selected for use in certain embodiments.Further, the modular nature of the Great vessel limbs, in someembodiments, provides versatility for stent selection and providesbuilt-in back-up systems so the surgeon can diverge from the plannedtreatment plan. These capabilities ensure that blood flow to end organsis maintained during the entire procedure.

Debranching Stent Graft Limb and Methods for Use

In a seventeenth aspect, the invention provides a debranching stentgraft limb comprising, (a) a main body stent graft limb with abifurcation defining a first leg and a second leg, wherein the main bodystent graft limb has a distal end and a proximal end, (b) wherein themain body stent graft limb has a diameter at the proximal end in therange from about 14 mm to about 18 mm, (c) wherein the first leg has adiameter ranging from about 8 mm to about 12 mm, (d) wherein the secondleg has a diameter ranging from about 6 mm to about 10 mm, and (e)wherein the distance from the proximal end of the main body to thedistal end of the first leg and the second leg is in the range fromabout 70 mm to about 90 mm, and wherein the diameter of the first leg isabout 2 mm greater than the diameter of the second leg.

In one embodiment, the seventeenth aspect further comprises (f) a firstlimb expanded within the first leg and coupled to the first leg viapassive fixation and (g) a second limb expanded within the second legand coupled to the second leg via passive fixation.

In an eighteenth aspect, the invention provides a method for placementof a debranching stent graft limb according to the seventeenth aspect ofthe invention, comprising, (a) introducing a guidewire into theappropriately sized branched arterial configuration via arterial access,(b) loading a delivery catheter containing a debranching stent graftlimb according to the seventeenth aspect of the invention onto theguidewire, (c) moving the delivery catheter along the guidewire andintroducing the delivery catheter into the appropriately sized branchedarterial configuration via the arterial access, and (d) deploying thedebranching stent graft limb into the appropriately sized branchedarterial configuration and/or a lumen of a previously-placed stentgraft, such as a stent graft according to the tenth, eleventh orthirteenth aspect of the invention.

In one embodiment, the eighteenth aspect of the invention furthercomprises (e) loading a second delivery catheter containing a first limbaccording to the seventeenth aspect of the invention onto a proximal endof the guidewire, (f) moving the second delivery catheter along theguidewire and introducing the second delivery catheter into the firstleg of the debranching stent graft limb via arterial access, and (g)deploying a proximal end of the first limb the first leg of thedebranching stent graft limb.

In another embodiment, the eighteenth aspect of the invention stillfurther comprises (h) introducing a second guidewire into theappropriately sized branched arterial configuration through the secondleg of a debranching stent limb according to the seventeenth aspect ofthe invention via arterial access, (i) loading a third delivery cathetercontaining a second limb according to the seventeenth aspect of theinvention onto the second guidewire, (j) moving the third deliverycatheter along the second guidewire and introducing the third deliverycatheter into the second leg of the debranching stent graft limb viaarterial access, and (k) deploying a proximal end of the second limbinto the second leg of the debranching stent graft limb in theappropriately sized branched arterial configuration.

In a nineteenth aspect, the invention provides a method for placement ofa debranching stent graft limb according to the seventeenth aspect ofthe invention, comprising, (a) introducing a guidewire into a commoniliac artery via arterial access, (b) loading a delivery cathetercontaining a debranching stent graft limb according to the seventeenthaspect of the invention onto the guidewire, (c) moving the deliverycatheter along the guidewire and introducing the delivery catheter intothe common iliac artery via arterial access, and (d) deploying thedebranching stent graft limb into the common iliac artery and/or a lumenof a previously-placed stent graft, such as a stent graft according tothe tenth, eleventh or thirteenth aspect of the invention.

The debranching stent graft limb and methods described with respect tothe seventeenth through the nineteenth aspects of the invention providenumerous benefits. For example, the debranching stent graft limb,deployed in combination with an embodiment of the debranching stentgraft, can be used for the treatment of any aneurysm of any anatomicalvariation or other type of diseased artery or traumatic injury. Thedebranching stent graft limb also beneficially adds another level ofdebranching via the first and second legs. This provides a built-inback-up system so the surgeon can diverge from the planned treatmentplan in during a debranching procedure.

The debranching stent graft limb has the additional advantage ofallowing for revision procedures. For example, if a patient with aprevious aortic aneurysm repair, such as a standard infra-renal stent,has a new aneurysm form in the common iliac, the treatment underprevious techniques would require embolization of the internal iliac.This is because previous up-and-over techniques would be blocked bypreviously placed stents. In this scenario, however, a top-down armapproach can be used to place debranching stent graft limb and then toplace extension stent grafts into the external and internal iliacarteries.

Combination Double-Barreled and Debranching Stent Grafts and Methods forUse

In a twentieth aspect, the invention provides a stent graft comprising,(a) a main body stent graft defining a single lumen and having a distalend and a proximal end, (b) a first bifurcation in the range from about20 mm to about 30 mm from the proximal end of the main body defining afirst lumen and a second lumen, wherein the main body stent graftdefines a tubular wall that is contiguous with the first lumen and thesecond lumen such that any fluid entering the main body stent graft mustexit by entering one of the first lumen or the second lumen, wherein themain body stent graft has a diameter at the proximal end in the rangefrom about 40 mm to about 60 mm, wherein the first lumen and the secondlumen each have a diameter in the range from about 18 mm to about 30 mm,wherein the length from the proximal end of the main body stent graft tothe distal end of the second lumen is in the range from about 70 mm toabout 90 mm, (c) a second bifurcation within the second lumen about 30mm from the distal end of the second lumen defining a first leg and asecond leg, wherein the first leg and the second leg each have adiameter in the range from about 14 mm to about 16 mm, and (d) a thirdbifurcation within the second leg about 20 mm to 30 mm distal from thesecond bifurcation defining a third leg and a fourth leg, wherein thethird leg and the fourth leg each have a diameter in the range fromabout 7 mm to about 12 mm, wherein the third and fourth leg each have alength in the range from about 20 mm to about 30 mm.

In one embodiment of the twentieth aspect, the first lumen is secured tothe second lumen along a shared length of about 30 mm.

In another embodiment of the twentieth aspect, the first lumen and thesecond lumen each retain a substantially cylindrical profile.

In a twenty-first aspect, the invention provides a stent graftcomprising, (a) a main body stent graft defining a single lumen andhaving a distal end and a proximal end, (b) a first bifurcation in therange from about 20 mm to about 30 mm from the proximal end of the mainbody defining a first lumen and a second lumen, wherein the main bodystent graft has a diameter at the proximal end in the range from about40 mm to about 60 mm, wherein the first lumen has a diameter in therange from about 20 mm to about 30 mm at the first bifurcation and has adiameter in the range from about 20 mm to 40 mm at the distal end of thefirst lumen, wherein the first lumen has a length of about 50 mm toabout 150 mm from the first bifurcation to the distal end of the firstlumen, wherein the second lumen has a diameter in the range from about20 mm to about 30 mm at the first bifurcation, (c) a second bifurcationwithin the second lumen about 30 mm from the distal end of the secondlumen defining a first leg and a second leg, wherein the first leg andthe second leg each have a diameter in the range from about 14 mm toabout 16 mm, wherein the length from the proximal end of the main bodystent graft to the distal end of the second lumen's second leg is in therange from about 50 mm to about 70 mm, and (d) a third bifurcationwithin the first leg that defines a third leg and a fourth leg, whereinthe third leg and the fourth leg each have a diameter from about 7 mm toabout 12 mm, wherein the third and fourth leg each have a length in therange from about 20 mm to about 30 mm.

In one embodiment of the twenty-first aspect, the first lumen is securedto the second lumen along a shared length from the first bifurcation tothe third bifurcation.

In a twenty-second aspect, the invention provides a method for placementof a stent graft according to one of the twentieth or twenty-firstaspects of the invention, comprising, (a) introducing a guidewire into athoracic aorta via arterial access, (b) loading a delivery cathetercontaining a stent graft according to one of the twentieth ortwenty-first aspects of the invention onto the guidewire, (c) moving thedelivery catheter along the guidewire and introducing the deliverycatheter into the thoracic aorta via arterial access, and (d) deployingthe stent graft into the thoracic aorta.

In a twenty-third aspect, the invention provides a method for placementof a stent graft according to one of the twentieth, twenty-first ortwenty-fifth aspects of the invention, comprising, (a) introducing aguidewire into an aorta via arterial access, (b) loading a deliverycatheter containing a stent graft according to one of the twentieth,twenty-first or twenty-fifth aspects of the invention onto theguidewire, (c) moving the delivery catheter along the guidewire andintroducing the delivery catheter into the aorta via arterial access,and (d) deploying the stent graft into the aorta.

In a twenty-fourth aspect, the invention provides a method for placementof a stent graft according to one of the twentieth or twenty-firstaspects of the invention, comprising, (a) introducing a guidewire intoan ascending aorta via arterial access, (b) loading a delivery cathetercontaining a stent graft according to one of the twentieth ortwenty-first aspects of the invention onto the guidewire, (c) moving thedelivery catheter along the guidewire and introducing the deliverycatheter into the ascending aorta via arterial access, and (d) deployingthe stent graft into the ascending aorta.

In a twenty-fifth aspect, the invention provides stent graft comprising(a) a main body stent graft defining a single lumen and having a distalend and a proximal end, (b) a first bifurcation in the main bodydefining a first lumen and a second lumen, where the main body stentgraft defines a tubular wall that is contiguous with the first lumen andthe second lumen such that any fluid entering the main body stent graftmust exit by entering one of the first lumen or the second lumen, wherethe main body stent graft has a diameter at the proximal end in therange from about 28 mm to about 42 mm, where the first lumen has adiameter in the range from about 22 mm to about 28 mm and the secondlumen has a diameter in the range from about 16 mm to about 22 mm, (c) asecond bifurcation within the first lumen defining a first leg and asecond leg, where the first leg and the second leg each have a diameterin the range from about 14 mm to about 16 mm, (d) a third bifurcationwithin the first leg about 0 mm to about 10 mm distal from the secondbifurcation defining a third leg and a fourth leg, where the third legand the fourth leg each have a diameter in the range from about 7 mm toabout 12 mm, where the third and fourth leg each have a length in therange from about 30 mm to about 50 mm, and (e) a fourth bifurcationwithin the second leg between about 10 mm and about 20 mm distal fromthe second bifurcation defining a fifth leg and a sixth leg, where thefifth leg and the sixth leg each have a diameter in the range from about7 mm to about 12 mm, where the fifth and sixth leg each have a length inthe range from about 30 mm to about 50 mm.

The stent graft and methods described with respect to the twentieththrough the twenty-fifth aspects of the invention provide numerousbenefits. One advantage over previously known single lumen main bodystent grafts, the combination double-barreled and debranching stentgraft can also be used as a “platform” or “anchor” that enables asurgeon to debranch Great vessels or visceral vessels, for example,while maintaining blood flow to the rest of the body without putting apatient on bypass, providing a significant improvement over priordevices and techniques. This anchoring main body stent graft can beutilized in combination with any embodiment of the debranching stentgrafts and/or stent graft limbs disclosed herein or with stent graftextenders. In one non-limiting example, the combination double-barreledand debranching stent graft can be used for the treatment of anyaneurysm of any anatomical variation or other type of diseased aorta ortraumatic injury.

Further, the combination double-barreled and debranching stent graft maybe deployed transapically, transfemorally, via the right subclavianartery, or via any other accessible artery. Unlike previously knownstent grafts, the combination double-barreled and debranching stentgraft can be deployed in the ascending aorta. When the combinationdouble-barreled and debranching stent graft is deployed in vivo, aorticflow is compartmentalized immediately, which increases surgical optionsby allowing the surgeon to engage in individual selection of the lumensfor placement of additional debranching stent grafts. The second lumenprovides a built-in back-up system in case an issue arises with stentplacement in the first lumen, for example. The combinationdouble-barreled and debranching stent graft also minimizes surgicalimpact on the patient and leads to reduced complication rates, reducedrisk of renal failure, bowel ischemia, and heart attack and decreasedtime for patient stabilization.

In addition, the contiguous nature of the walls of the combinationdouble-barreled and debranching stent graft's main body with the firstand second lumens has the additional benefit of preventing extraneousblood flow into the aneurysm. The walls of the combinationdouble-barreled and debranching stent graft provide a completecircumferential seal and there is no external compromise or compressionof the lumen walls, which prevents blood flow through the lumens frombeing affected. Previous “sandwich,” “snorkel” and “chimney” deviceswere constructed by simultaneously placing two or more single lumenstent grafts side by side within the aorta. These previous stent graftsdefined open spaces where the walls of the internal lumens did notcompletely abut each other or the aortic walls and allowed blood to flowthrough the open spaces and into the aneurysm. These previous deviceswere further subject to collapse or compression due to externalpressures.

In addition, the cylindrical nature of walls of the combinationdouble-barreled and debranching stent graft provide more positivefixation with the wall of the aorta than provided by previous devices.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an isometric view illustrating the dimensions of oneembodiment of a double-barreled stent graft according to the firstaspect of the invention.

FIG. 1B is an isometric view of one embodiment of a double-barreledstent graft according to the first aspect of the invention.

FIG. 2A is an isometric view illustrating the dimensions of oneembodiment of a double-barreled stent graft according to the secondaspect of the invention.

FIG. 2B is an isometric view of one embodiment of a double-barreledstent graft according to the second aspect of the invention.

FIG. 3 is a cross-sectional view of a thoracic abdominal aortic aneurysmwith an isometric view of one embodiment of a double-barreled stentgraft, a debranching visceral stent graft and multiple stent graftextenders after deployment during a debranching procedure.

FIG. 4A is an isometric view illustrating the dimensions of oneembodiment of a double-barreled stent graft according to the sixthaspect of the invention.

FIG. 4B is an isometric view of one embodiment of a double-barreledstent graft according to the sixth aspect of the invention.

FIG. 5A is an isometric view of one embodiment of a double-barreledstent graft according to the sixth aspect of the invention with acylindrical stent graft structure disposed on an exterior of the mainbody stent graft.

FIG. 5B is an isometric view of one embodiment of a double-barreledstent graft according to the sixth aspect of the invention with acylindrical stent graft structure disposed on an exterior of the mainbody stent graft and a stent valve attached to the proximal end of themain body stent graft.

FIG. 6 is a cross-sectional view of the ascending aorta and the proximaldescending aorta with an isometric view of one embodiment of adouble-barreled stent graft including a stent valve, a debranchingvisceral stent graft and multiple stent graft extenders after deploymentduring a debranching procedure.

FIG. 7A is an isometric view illustrating the dimensions of oneembodiment of a debranching visceral stent graft according to the tenthaspect of the invention as well as example modular visceral limbscoupled with passive fixation, for example.

FIG. 7B is an isometric view of one embodiment of a debranching visceralstent graft according to the tenth aspect of the invention as well asexample modular visceral limbs coupled with passive fixation, forexample.

FIG. 8A is an isometric view illustrating the dimensions of oneembodiment of a debranching visceral stent graft according to the tenthaspect of the invention with visceral limbs in a unitary configuration.

FIG. 8B is an isometric view of one embodiment of a debranching visceralstent graft according to the tenth aspect of the invention with viscerallimbs in a unitary configuration.

FIG. 9A is an isometric view illustrating the dimensions of oneembodiment of a debranching visceral stent graft according to the tenthaspect of the invention with a visceral limb in a unitary configuration.

FIG. 9B is an isometric view of one embodiment of a debranching visceralstent graft according to the tenth aspect of the invention with avisceral limb in a unitary configuration.

FIG. 10A is an isometric view illustrating the dimensions of oneembodiment of a debranching visceral stent graft according to theeleventh aspect of the invention with a visceral limb joined to thefirst leg in a unitary configuration and a visceral extension deployedwithin the second leg.

FIG. 10B is an isometric view of one embodiment of a debranchingvisceral stent graft according to the eleventh aspect of the inventionwith a visceral limb joined to the first leg in a unitary configurationand a visceral extension deployed within the second leg.

FIG. 11A is an isometric view illustrating the dimensions of oneembodiment of a debranching Great vessel stent graft according to thethirteenth aspect of the invention with a Great vessel limb joined tothe first leg in a unitary configuration.

FIG. 11B is an isometric view of one embodiment of a debranching Greatvessel stent graft according to the thirteenth aspect of the inventionwith a Great vessel limb joined to the first leg in a unitaryconfiguration.

FIG. 12A is an isometric view illustrating the dimensions of oneembodiment of a debranching Great vessel stent graft according to thethirteenth aspect of the invention with a Great vessel limb joined tothe first leg in a unitary configuration.

FIG. 12B is an isometric view one embodiment of a debranching Greatvessel stent graft according to the thirteenth aspect of the inventionwith a Great vessel limb joined to the first leg in a unitaryconfiguration.

FIG. 13A is an isometric view illustrating the dimensions of oneembodiment of a Great vessel limb according to the thirteenth aspect ofthe invention with a Great vessel limb for deployment and passivefixation in a debranching Great vessel stent graft.

FIG. 13B is an isometric view of one embodiment of a Great vessel limbaccording to the thirteenth aspect of the invention with a Great vessellimb for deployment and passive fixation in a debranching Great vesselstent graft.

FIG. 14A is an isometric view illustrating the dimensions of oneembodiment of a debranching stent graft limb according to theseventeenth aspect of the invention.

FIG. 14B is an isometric view of one embodiment of a debranching stentgraft limb according to the seventeenth aspect of the invention.

FIG. 15A is a cross-sectional view of the abdominal aorta with anisometric view of one embodiment of a debranching stent graft limbaccording to the seventeenth aspect of the invention after deploymentduring a debranching procedure.

FIG. 15B is a detail view of a cross-section of the aneurysmal sac withan isometric view of one embodiment of a debranching stent graft limbaccording to the seventeenth aspect of the invention after deploymentduring a debranching procedure.

FIG. 16A is an isometric view illustrating the dimensions of oneembodiment of a combination double-barreled and debranching stent graftaccording to the twentieth aspect of the invention.

FIG. 16B is an isometric view of one embodiment of a combinationdouble-barreled and debranching stent graft according to the twentiethaspect of the invention.

FIG. 17A is an isometric view illustrating the dimensions of oneembodiment of a combination double-barreled and debranching stent graftaccording to the twenty-first aspect of the invention.

FIG. 17B is an isometric view of one embodiment of a combinationdouble-barreled and debranching stent graft according to thetwenty-first aspect of the invention.

FIG. 18 is a cross-sectional view of the ascending aorta and theproximal descending aorta with an isometric view of one embodiment of acombination double-barreled and debranching stent graft including astent valve according to the twenty-first aspect of the invention andmultiple stent graft extenders after deployment during a debranchingprocedure.

FIG. 19A is an isometric view illustrating the dimensions of oneembodiment of a combination double-barreled and debranching stent graftaccording to the twenty-fifth aspect of the invention.

FIG. 19B is an isometric view of one embodiment of a combinationdouble-barreled and debranching stent graft according to thetwenty-fifth aspect of the invention.

DETAILED DESCRIPTION

The present disclosure provides for stent grafts and methods for ananchoring main body stent and/or bridging a defect in a main vessel nearone or more branch vessels, for example at or in the vicinity of abifurcation in the arterial system of a patient.

As used herein, “endo-debranching” is an endovascular surgical techniquethat refers to placing stent grafts in series to exclude (repair)diseased aorta and to place stent grafts into the branch vesselsconnected with the aneurysmal sac and/or other vessels, thus allowingexclusion (repair) of the diseased aorta while maintaining blood flow.

As used herein, “branch vessel” refers to a vessel that branches offfrom a main vessel. The “branch vessels” of the thoracic and abdominalaorta include the innominate, left common carotid, left subclavian,celiac, superior mesenteric arteries, renal(s), and all other minorbranches. This does not limit the division of the aorta into the iliacarteries. As another example, the hypogastric artery is a branch vesselto the common iliac, which is a main vessel in this context. Thus, itshould be seen that “branch vessel” and “main vessel” are relativeterms.

As used herein, “Great vessels” includes the right innominate, the leftcommon carotid, and the left subclavian arteries.

As used herein, “diseased aorta” refers to any diseased portion of theaorta extending from and including the aortic outflow tract to thefemoral arteries.

As used herein, “passive fixation” refers to friction, interactionbetween the cloth of the grafts, radial strength of the stent and bloodpressure that holds the component stent grafts together at the site ofoverlap. All stent graft components joined together via passive fixationcould further include, or alternatively be joined by, adhesives, apolymeric reaction between an inner coating on the receiving stent graftand an outer coating on the stent graft being deployed resulting in abond or any other fixation method.

As used herein, an “anchoring main body stent graft” refers to the firststent placed during a debranching procedure, where that first stentgraft is in direct contact with a non-diseased portion of the arterialvessel wall.

As used herein, with respect to measurements, “about” means +/−5%.

As used herein, with respect to cylindrical configurations or profilesand constant lumen diameters, “substantially” means being largely but,in some instances, not wholly that which is specified. In other words,lumens and cylinders may not be perfectly round.

As used herein, a “fenestration” refers to perforations within stentgraft walls intended to be aligned with the opening of a given branchvessel.

As used herein, a “stent graft” is a tubular, radially-expandable devicecomprising a fluid-tight fabric supported by a stent, and is used tobridge diseased arteries. Such stent grafts and methods for theirdeployment and use are known to those of skill in the art. For example,vascular sheaths can be introduced into the patient's arteries, throughwhich items, including but not limited to, guidewires, catheters and,eventually, the stent graft, is passed.

As used herein, “stent” is typically a cylindrical frame and means anydevice or structure that adds rigidity, expansion force, or support to aprosthesis, while “stent graft” refers to a prosthesis comprising astent and a graft material associated therewith that forms a fluid-tightlumen through at least a portion of its length. A “graft” is acylindrical liner that may be disposed on the stent's interior, exterioror both. A wide variety of attachment mechanisms are available to jointhe stent and graft together, including but not limited to, sutures,adhesive bonding, heat welding, and ultrasonic welding.

The stent can be made of any suitable material, including but notlimited to biocompatible metals, implantable quality stainless steelwires, nickel and titanium alloys, and biocompatible plastics attachedto a graft. Any suitable fluid tight graft material can be used. In apreferred embodiment, the graft material is a biocompatible fabric,including but not limited to woven or knitted polyester, such aspoly(ethylene terephthalate), polylactide, polyglycolide and copolymersthereof; fluorinated polymers, such as PTFE, expanded PTFE andpoly(vinylidene fluoride); polysiloxanes, including polydimethylsiloxane; and polyurethanes, including polyetherurethanes, polyurethaneureas, polyetherurethane ureas, polyurethanes containing carbonatelinkages and polyurethanes containing siloxane segments. Materials thatare not inherently biocompatible may be subjected to surfacemodifications in order to render the materials biocompatible. Examplesof surface modifications include graft polymerization of biocompatiblepolymers from the material surface, coating of the surface with acrosslinked biocompatible polymer, chemical modification withbiocompatible functional groups, and immobilization of a compatibilizingagent such as heparin or other substances. The graft material may alsoinclude extracellular matrix materials.

The covered stent grafts can be made of any suitable material, includingbut not limited topolytetrafluoroethylene (ePTFE) lined nickel-titaniumalloy stent. The stent grafts are preferably covered and flexible. Thestent grafts may contain any other suitable components, such as surfacemodifications including but not limited to covalent attachment ofheparin.

The stent grafts according to the various embodiments may comprise aunitary structure that can be achieved by joining pre-fabricated lumens,legs and limbs via one or more of a common graft covering, stitching,adhesive, bonding, welding or any other technique known in the art.

As used herein, a “common graft covering” refers to an uninterruptedcontinuous stent graft covering that extends from a single lumen or legover at least one bifurcation and may overlap with another common graftcovering. This common graft covering may be pulled over a bifurcation ina similar fashion to that of pulling on pants.

The stent graft components can be variously sized (i.e.: length,diameter, etc.) as suitable for an intended use, and are preferablylarger in diameter than the inner vessel diameter to be treated. Forexample, aortic components can be oversized by approximately 10-20%;limb components can be oversized by approximately 25%.

The stent grafts of the present invention may contain any furthersuitable components, including but not limited to radiopaque markers toaid in visualization and to facilitate accurate placement of the stentgraft. These radiopaque markers may take the form of gold bands at thedistal end of each individual lumen of a given stent graft or adirectional marker, for example in the shape of an “S” or any othersuitable form for indicating direction and orientation of the stentgraft. In addition, bi-directional anchoring hooks formed as part of thetwo most proximal individual stents of a given stent graft may beutilized to gain solid purchase in the non-diseased portion of a vesselwall. Further, a fixation stent may be used at the proximal end of amain body stent graft that allows for radial force fixation within thevessel in conjunction with bidirectional hooks.

Double-Barreled Stent Grafts

The double-barreled stent graft can be used for the treatment of anyaneurysm of any anatomical variation or other type of diseased aorta ortraumatic injury.

Visceral Double-Barreled Main Body Stent Graft and Methods for Use

In a first aspect, as exemplified in FIGS. 1A and 1B, the inventionprovides a stent graft 100 comprising, (a) a main body stent graft 105having a distal end 106 and a proximal end 107, wherein the main bodystent graft 105 has a length in the range from about 100 mm to about 120mm, wherein the main body stent graft 105 has a diameter at the proximalend 107 in the range from about 30 mm to about 45 mm, (b) a first lumen110 defined at the distal end 106 of the main body stent graft 105,wherein the first lumen 110 has a diameter in the range from about 18 mmto about 20 mm, (c) a second lumen 115 defined at the distal end 106 ofthe main body stent graft 105, wherein the second lumen 115 has adiameter in the range from about 16 mm to about 18 mm, wherein the firstlumen 110 and the second lumen 115 have the same length of about 50 mmto about 70 mm, wherein the first lumen 110 is secured to the secondlumen 115 along a shared length 120, and (d) wherein the main body stentgraft 105 defines a tubular wall 125 that is contiguous with the firstlumen 110 and the second lumen 115 such that any fluid entering the mainbody stent graft 105 must exit through one of the first lumen 110 or thesecond lumen 115.

In one embodiment, the double barreled main body stent graft 100 can bemade by joining two existing single lumen stent graft extensions orlimbs to the complete periphery of a distal end of an existing singlelumen main body stent graft and then joining the two single lumenextensions and/or limbs to one another along a shared length. The mainbody stent graft can be joined with two existing single lumen stentgrafts using adhesive, sewing, bonding, or welding, or any other knownmechanism, for example. The same means can be used to join the twosingle lumens along a shared length. This embodiment maintains the twosingle lumen extensions or limbs in a substantially cylindricalconfiguration. In a further embodiment, the double barreled main bodystent graft can be made by sewing a seam partially or completely up themiddle of an existing stent graft, to create the two separate “barrels”or lumens. In another embodiment, the double barreled main body stentgraft can be clamped partially or completely up the middle of anexisting stent graft, to create the two separate lumens. Alternatively,the double-barreled main body stent graft can be manufactured as unitarydual lumen device using any suitable process. Using a seam or clamptechnique allows the tubular wall 125 of the main body stent graft 105to remain contiguous with the walls of first lumen 110 and the secondlumen 115 such that any fluid entering the main body must exit throughone of the first lumen 110 or the second lumen 115.

In a preferred embodiment, the double-barreled stent graft 100 can beused as an anchoring main body stent graft for debranching procedures.

In one embodiment, the shared length 120 of the first and second lumensis a minimum of about 30 mm. This length provides adequate overlap forpassive fixation to other modular stent grafts, for example, debranchinggreat vessel stent grafts, debranching visceral stent grafts, extensionstent grafts, other stent grafts of the present invention, or any otherlimb-type stent graft during stent graft debranching procedures.

In one embodiment, the first lumen 110 and the second lumen 115 aredefined by a seam 121 at the distal end of the main body graft. As shownin FIGS. 1B and 2B, the proximal end 107, 207 of the main body stentgraft 105, 205 remains substantially cylindrical to maintain a completeseal with the aortic wall. In another embodiment, the visceraldouble-barreled stent graft 100, 200 further includes a cylindricalstent graft structure, discussed in detail with respect to the sixthaspect of the invention, that is coextensive with and disposed on anexterior of the main body stent graft 105, 205.

In another embodiment, the diameter of the first lumen 110 is about 2 mmgreater than the diameter of the second lumen 115. In a preferredembodiment, the diameter of the first lumen 110 is about 18 mm and thediameter of the second lumen 115 is about 16 mm. In various embodiments,the diameter of the first lumen 110 may be between about 18-20 mm, 19-20mm or 20 mm, while the diameter of the second lumen 115 may be betweenabout 16-18 mm or about 16-17 mm.

In a further embodiment, the length of the main body stent graft 105 isabout 100 mm and, in various embodiments, may be between about 100-120mm, 100-115 mm, 100-110 mm, 100-105 mm, 105-120 mm, 110-120 mm, 115-120mm or about 120 mm.

In various embodiments, the diameter of the proximal end of the mainbody stent graft may be between about 30-45 mm, 32-43 mm, 35-40 mm, 30mm, 35 mm, 40 mm or about 45 mm.

In a second aspect, as shown in FIGS. 2A and 2B, the invention providesa stent graft 200 comprising, (a) a main body stent graft 205 having adistal end 206 and a proximal end 207, wherein the main body stent graft205 has a length in the range from about 100 mm to about 120 mm, (b) afirst lumen 210 defined about 5 mm from the proximal end 207 of the mainbody stent graft 205 to the distal end 206 of the main body 205, whereinthe first lumen 210 has a substantially constant diameter along itslength in the range from about 18 mm to about 20 mm, (c) a second lumen220 defined about 5 mm from the proximal end 207 of the main body stentgraft 205 to the distal end 206 of the main body stent graft 205,wherein the second lumen 215 has a substantially constant diameter alongits length in the range from about 16 mm to about 18 mm, wherein thefirst lumen 210 is secured to the second lumen 215 along a shared length220.

The main body stent graft 205 defines a single lumen with a uniform sidewall at the proximal end 207 extending 5 mm towards the distal end 206to ensure that the profile of the proximal end 207 remains substantiallycylindrical to maintain a complete seal with the aortic wall.

Any of the additional embodiments discussed with respect to the firstaspect of the invention can likewise be used with the second aspect ofthe invention.

In a third aspect, see for example FIG. 3, the invention provides amethod for placement of a stent graft 100, 200 according to the first orsecond aspects of the invention, comprising, (a) introducing a guidewireinto an aorta 300 via arterial access, (b) loading a delivery cathetercontaining a stent graft 100, 200 according to the first or secondaspects of the invention onto the guidewire, (c) moving the deliverycatheter along the guidewire and introducing the delivery catheter intothe aorta 300 via arterial access, and (d) deploying the stent graft100, 200 into the aorta 300.

In one example, FIG. 3 shows a visceral double-barreled main body stentgraft 100 acting as a platform or anchor. A debranching visceral stentgraft 800 is deployed within the first lumen 110 of the double-barreledmain body stent graft 100 and a visceral extension stent graft 305 isdeployed within the second lumen 115. Additional extension stent graftsand a bifurcated stent graft are linked in series across the aneurysmalsac 301 to the native vessels 302 to complete the debranching of theaneurysm.

In one embodiment, the visceral double-barreled stent grafts 100, 200may be used in an antegrade deployment in the thoracic aorta in thenormal direction of blood flow. In an example visceral antegradedeployment, the distal portion of the stent graft can be placed about 11cm above the celiac artery. In this antegrade deployment, one of thefirst or second lumens of the double-barreled stent grafts is dedicatedto the visceral segment of the aorta, while the other lumen is dedicatedto the revascularization of the infra-renal aorta.

In a fourth aspect, not shown, the invention provides a method forplacement of a stent graft 100, 200 according to the first or secondaspects of the invention, comprising, (a) introducing a guidewire intoan aortic arch via arterial access, (b) loading a delivery cathetercontaining a stent graft 100, 200 according to the first or secondaspects of the invention onto the guidewire, wherein a distal end 106,206 of the stent graft is loaded first, (c) moving the delivery catheteralong the guidewire and introducing the delivery catheter into theaortic arch via arterial access, and (d) deploying the stent graft 100,200 into a proximal descending aorta.

In a fifth aspect, not shown, the invention provides a method forplacement of a stent graft 100, 200 according to the first or secondaspects of the invention, comprising, (a) introducing a guidewire into athoracic or abdominal aorta via arterial access, (b) loading a deliverycatheter containing a stent graft 100, 200 according to the first orsecond aspects of the invention onto the guidewire, (c) moving thedelivery catheter along the guidewire and introducing the deliverycatheter into the thoracic or abdominal aorta via arterial access, and(d) deploying the stent graft 100, 200 into the thoracic or abdominalaorta.

In one embodiment, a main body of a debranching stent graft is sized soas to slide into one of the lumens of the double-barreled main bodystent graft, while the other lumen can be used for stenting of a lowerextremity, such as the infrarenal segment. In one embodiment, hedebranching stent graft is held in place through passive fixation.

Aortic Arch Double-Barreled Main Body Stent Graft and Methods for Use

In a sixth aspect, as shown in FIGS. 4A and 4B, the invention provides astent graft 400 comprising, (a) a main body stent graft 405 having adistal end 406 and a proximal end 407 wherein the main body stent graft405 has a length in the range from about 50 mm to about 70 mm, whereinthe main body stent graft 405 has a diameter at the proximal end 407 inthe range from about 40 mm to about 60 mm, (b) a first lumen 410 definedat the distal end of the main body stent graft 405, wherein the firstlumen 410 has a diameter in the range from about 18 mm to about 30 mm,(b) a second lumen 415 defined at the distal end 406 of the main bodystent graft 405, wherein the second lumen 415 has a diameter in therange from about 18 mm to about 30 mm, (c) wherein the first lumen 410is secured to the second lumen 415 along a shared length 420, whereinthe shared length of the first lumen 410 and the second lumen 415 is inthe range from about 30 mm to about 65 mm, and (d) wherein the main bodystent graft 405 defines a tubular wall 425 that is contiguous with thefirst lumen 410 and the second lumen 415 such that any fluid enteringthe main body stent graft 405 must exit through one of the first lumen410 or the second lumen 415.

In one embodiment, the double barreled main body stent graft 400 can bemade by joining two existing single lumen stent graft extensions orlimbs to the complete periphery of a distal end of an existing singlelumen main body stent graft and then joining the two single lumenextensions and/or limbs to one another along a shared length. The mainbody stent graft can be joined with two existing single lumen stentgrafts using adhesive, sewing, bonding, or welding, or any other knownmechanism, for example. The same means can be used to join the twosingle lumens along a shared length. This embodiment maintains the twosingle lumen extensions or limbs in a substantially cylindricalconfiguration. In a further embodiment, the double barreled main bodystent graft can be made by sewing a seam partially or completely up themiddle of an existing stent graft, to create the two separate “barrels”or lumens. In another embodiment, the double barreled main body stentgraft can be clamped partially or completely up the middle of anexisting stent graft, to create the two separate lumens. Alternatively,the double-barreled main body stent graft can be manufactured as unitarydual lumen device using any suitable process. Using a seam or clamptechnique allows the tubular wall 425 of the main body stent graft 405to remain contiguous with the walls of first lumen 410 and the secondlumen 415 such that any fluid entering the main body must exit throughone of the first lumen 410 or the second lumen 415.

In one embodiment of the sixth aspect of the invention, the first lumenand the second lumen are defined by a seam 421 starting at the distalend 406 of the main body stent graft 405 and extending towards theproximal end 407 of the main body stent graft 405. In one preferredembodiment, the shared length 421 of the first lumen 410 and the secondlumen 415 is about 30 mm and, in various embodiments, the shared length421 may be between about 30-65 mm, 30-60 mm, 30-55 mm, 30-50 mm, 30-45mm, 30-40 mm or 30-35 mm. Alternatively, the shared length 421 of thefirst lumen 410 and the second lumen 415 is about 70 mm.

In various embodiments, the length of the main body stent graft 405 maybe between about 50-70 mm, 50-65 mm, 50-60 mm, 50-55 mm, 50 mm, 55-70mm, 60-70 mm, 65-70 mm or about 70 mm.

In one embodiment, the diameter of the first lumen 410 is about the sameas the diameter of the second lumen 415. In one preferred embodiment,the diameter of the first lumen 410 is about 20 mm and the diameter ofthe second lumen 415 is about 20 mm. In various embodiments, thediameter of the first lumen 410 may be between about 18-30 mm, 20-28 mm,22-26 mm, or 24 mm. In various embodiments, the diameter of the secondlumen 415 may be between about 18-30 mm, 20-28 mm, 22-26 mm or about 24mm.

In another preferred embodiment, the main body stent graft 405 has adiameter at the proximal end 406 of about 40 mm. In still anotherpreferred embodiment, the length of the main body stent graft 405 isabout 50 mm and, in various embodiments, the length of the main bodystent graft 405 may be between about 40-60 mm, 42-58 mm, 44-56 mm, 46-54mm, 48-52 mm, 40 mm or about 60 mm.

In another embodiment, as shown in FIG. 5A, the sixth aspect of theinvention further comprises a cylindrical stent graft structure 430coextensive with and disposed on an exterior of the main body stentgraft 405. The cylindrical stent graft structure 430 maintains thedouble-barreled stent graft 400 in a substantially cylindrical shape toassist with facial contact with the vessel wall along the length of thestent graft resulting in a complete circumferential seal and to ensureblood flow is maintained through both lumens 410, 415. When thedouble-barreled stent graft 400 is deployed in the ascending aorta orthe proximal descending aorta, maintaining the cylindrical shape of thedouble-barreled stent graft 400 is particularly important.

In one embodiment, the cylindrical stent graft structure 430 may furtherdefine bi-directional anchor hooks 435. These bi-directional anchorhooks 435 attach to the aortic wall preventing or limiting migration ofthe main body stent graft 405 within the aorta.

In another embodiment, the cylindrical stent graft structure 430 mayfurther include radiopaque markers 440 in the form of gold bands at thedistal end of each individual lumen of a given stent graft. Theseradiopaque markers 440 help the surgeon ensure that the double-barreledstent graft 400 is properly oriented within the aorta prior todeployment and further assist with guidewire placement within the firstand/or second lumens 410, 415.

In yet another embodiment, the cylindrical stent graft structure 430 mayfurther include a directional marker 445 of any shape or configuration,for example, an “S” shape. The directional marker 445 helps the surgeonensure that the double-barreled stent graft 400 is properly orientedwithin the aorta prior to deployment.

In one embodiment, shown in FIG. 5B, a stent valve 445 is affixed to theproximal end 407 of the main body stent graft 405, where a free end 446of the stent valve 445 is covered and a portion of the stent valve 447extending between the free end 446 and the proximal end 407 of the mainbody stent graft 405 is uncovered. As used herein, a “stent valve” is apercutaneous self-expanding valve affixed to a proximal end 407 of themain body stent graft 405 with the uncovered portion 447 overlaying thecoronary arteries 455 to maintain blood flow. An exemplary embodiment ofthe stent valve includes the Corevalve® manufactured by Medtronic. Inone embodiment, the free end 446 of the stent valve 445 is covered withan impervious natural or synthetic material. In one embodiment, thestent valve 445 may be placed in the outflow tract 451 of the aorticvalve. The stent valve's anchoring mechanism is derived from, forexample, a funnel shape with a larger diameter at the free end 446 andsmaller diameter at the point where the covered portion meets theuncovered portion 447. This embodiment may be used in combination withany of the anchoring main body stent grafts of the present invention.

In a seventh aspect, the invention provides a method for placement of astent graft 400 from the sixth aspect of the invention, comprising, (a)introducing a guidewire into an aorta via arterial access, (b) loading adelivery catheter containing a stent graft 400 according to the sixthaspect of the invention onto the guidewire, (c) moving the deliverycatheter along the guidewire and introducing the delivery catheter intothe aorta via arterial access, and (d) deploying the stent graft 400into the aorta.

In one embodiment, the seventh aspect further comprises (e) loading asecond delivery catheter containing a debranching stent graft 1100according to the thirteenth aspect of the invention onto the guidewire,(f) moving the second delivery catheter along the guidewire andintroducing the delivery catheter into the aorta via arterial access,and (g) deploying the debranching stent graft 1100 into one of the aortaor a lumen of a previously-placed stent graft, such as a stent graft 400according to the sixth aspect of the invention within the aorta.

In one embodiment, a main body of the debranching stent graft 1100 issized so as to slide into one of the lumens of the double-barreled mainbody stent graft 400, while the other lumen can be used an extensionstent graft. In one embodiment, the debranching stent graft 1100 andextension stent graft are held in place through passive fixation.

In another embodiment, the seventh aspect still further comprises, (h)introducing a second guidewire into the aorta via arterial access, (i)loading a third delivery catheter containing a great vessel limb 1325according to the thirteenth aspect of the invention onto the secondguidewire, (j) moving the third delivery catheter along the secondguidewire and introducing the third delivery catheter into a selectedleg of the debranching stent graft 1100 via arterial access, and (k)deploying a proximal end 1326 of the great vessel limb 1325 into theselected leg of the debranching stent graft 1100.

In an eighth aspect, the invention provides a method for placement of astent graft 400 from the sixth aspect of the invention, comprising, (a)introducing a guidewire into an aortic arch via arterial access, (b)loading a delivery catheter containing a stent graft 400 according tothe sixth aspect of the invention onto the guidewire, wherein a distalend 406 of the stent graft 405 is loaded first, (c) moving the deliverycatheter along the guidewire and introducing the delivery catheter intothe aortic arch via arterial access, and (d) deploying the stent graft400 into a proximal descending aorta.

In another embodiment, the aortic arch double-barreled stent graft maybe used in a retrograde deployment in the aortic arch against the normaldirection of blood flow. In the retrograde deployment, the proximalportion of the stent graft can be placed about 11 cm distal to the leftsubclavian artery. In this retrograde deployment, one of the first orsecond lumens is dedicated to the Great vessels, while the other lumenis dedicated to the ascending aorta.

In a ninth aspect, as shown in FIG. 6, the invention provides a methodfor placement of a stent graft 400 from the sixth aspect of theinvention, comprising, (a) introducing a guidewire into an ascendingaorta 450 via arterial access, (b) loading a delivery cathetercontaining a stent graft 400 according to the sixth aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the ascending aorta450 via arterial access, and (d) deploying the stent graft 400 into oneor both of an aortic outflow tract 451 or the ascending aorta 450.

In one embodiment, the double-barreled stent graft 400 may be used in anantegrade deployment in the ascending aorta 450 in the normal directionof blood flow. This is considered a “transapical” approach. As usedherein, the “transapical” approach is made through the left ventriclethrough an apex of the heart into the ascending aorta 450 in order todebranch the aortic arch in an antegrade manner. Specifically, thedouble barrel stent graft 400 is loaded in a catheter in reverse anddeployed antegrade. In this transapical antegrade deployment, theproximal portion of the double-barreled stent graft 400 is deployedwithin about one centimeter of the aortic valve coronary arteries 455.In the embodiment utilizing a stent valve 445, the free covered end 446of the stent valve lies in the aortic outflow tract 451, while theuncovered portion 447 of the stent valve lays across the coronaryarteries 455 permitting blood flow to continue in a normal manner.According to this transapical antegrade deployment, one of the first orsecond lumens 410, 415 of the double-barreled stent graft 400 isdedicated to the innominate artery 452, while the other lumen isdedicated to the left common carotid 453 and the left subclavianarteries 454.

Debranching Stent Grafts

The debranching stent grafts can be used for the treatment of anyaneurysm of any anatomical variation or other type of diseased aorta ortraumatic injury. The debranching stent grafts, in particular, are ableto connect to almost any vessel anatomy, and thus provide an ease of usein a variety of different patients. In addition, the debranching stentgraft can be used in combination with any embodiment of thedouble-barreled stent graft or stent graft limb disclosed herein, orother main body anchoring stent graft. The core debranching stent graftcomprises a main body stent graft with a bifurcation defining a firstleg and a second leg. This core can be used modularly with limbs thatmay be selected based on the debranching procedure required and a givenpatient's vasculature.

Debranching Visceral Stent Graft and Methods for Use

In a tenth aspect, as shown in FIGS. 7A-9B, the invention provides adebranching stent graft 700, 800, 900 comprising, (a) a main body stentgraft 705, 805, 905 with a bifurcation 710, 810, 910 defining a firstleg 715, 815, 915 and a second leg 720, 820, 920, wherein the main bodystent graft 705, 805, 905 has a distal end 706, 806, 906 and a proximalend 707, 807, 907, (b) wherein the main body stent graft 705, 805, 905has a diameter at the proximal end 707, 807, 907 in the range from about18 mm to about 22 mm, (c) wherein the first leg 715, 815, 915 and thesecond leg 720, 820, 920 each have a diameter in the range from about 14mm to about 16 mm, (d) wherein the distance from the proximal end 707,807, 907 of the main body stent graft 705, 805, 905 to the distal end706, 806, 906 of the first leg 715, 815, 915 is in the range from about70 mm to about 90 mm, (e) and wherein the distance from the proximal end707, 807, 907 of the main body stent graft 705, 805, 905 to the distalend 721, 821, 921 of the second leg 720, 820, 920 is in the range fromabout 80 mm to about 100 mm, and wherein the second leg 720, 820, 920 isat least about 10 mm longer than the first leg 715, 815, 915. Likenumbers denote like features in FIGS. 7A-9B.

The debranching visceral stent graft 700 may be deployed within a lumenof a double-barreled main body stent graft as a second level in adebranching procedure or placed in direct contact with a vessel wall asan anchoring main body stent graft. In addition, the debranchingvisceral stent graft 700, 800, 900 could be deployed in the lumen of anypreviously-placed appropriately sized stent graft.

In one preferred embodiment, the second leg 720, 820, 920 is no morethan about 20 mm longer than the first leg 715, 815, 915. The differencein length between the two legs allows for a smaller constraining deviceto be used for deployment and further eases selection of the individualvessels for stenting by providing a better radiographical visualizationof the legs. In a further preferred embodiment, the distance from theproximal end 707, 807, 907 of the main body stent graft 705, 805, 905 tothe distal end 706, 806, 906 of the first leg 715, 815, 915 is about 70mm, and the distance from the proximal end 707, 807, 907 of the mainbody stent graft 705 to the distal end of the second leg 720 is about 80mm. In various embodiments, the distance from the proximal end 707, 807,907 of the main body stent graft 705, 805, 905 to the distal end 706,806, 906 of the first leg 715, 815, 915 may be between about 70-90 mm,70-85 mm, 70-80 mm or 70-75 mm. In various embodiments, the distancefrom the proximal end 707, 807, 907 of the main body stent graft 705,805, 905 to the distal end of the second leg 720, 820, 920 may bebetween about 80-100 mm, 80-95 mm, 80-90 mm or 80-85 mm.

In another preferred embodiment, the bifurcation 710, 810, 910 occurs inthe range from about 30 mm to about 40 mm from the proximal end 707,807, 907. This provides 30-40 mm for passive fixation with a lumen of ananchoring double-barreled main body stent graft 100, 200 or any otheranchoring stent graft and/or 30-40 mm of substantially cylindrical wallat the proximal end 707, 807, 907 of the main body stent graft 705, 805,905 for direct facial contact with the aortic wall when the debranchingvisceral stent graft 700, 800, 900 is acting as a main body anchor.

In an additional preferred embodiment, the diameter of the main bodystent graft 705, 805, 905 at the proximal end 707, 807, 907 is about 20mm and, in various embodiments, may be between about 18-22 mm, 19-22 mm,20-22 mm, 21-22 mm or about 22 mm.

In one embodiment, the tenth aspect of the invention further comprises afirst visceral limb 725, 825, 925 joined with one of the first leg 715,815, 915 or the second leg 720, 820, 920 at the distal end of the mainbody stent graft 705, 805, 905.

In a preferred embodiment, as shown in FIGS. 8A-9B, the first viscerallimb 825, 925 is joined with one of the first leg 815, 915 or the secondleg 820, 920 via a seam 831, 931. In this embodiment, the first viscerallimb 825, 925 preferably has a diameter at the proximal end 826, 926 ofabout 14 mm and, in various embodiments, may be between about 14-16 mmor 14-15 mm. Further in this embodiment, the first visceral limb 825,925 preferably has a length in the range from about 30 mm to about 50 mmand, in various embodiments, may be between about 30-45 mm, 30-40 mm,30-35 mm or about 30 mm. Also in this embodiment, the first viscerallimb 825, 925 may have a bifurcation 830, 930 defining a third leg 835,935 and a fourth leg 840, 940, and the bifurcation 830, 930 preferablyoccurs approximately at the seam. Here, each of the third leg 835, 935and the fourth leg 840, 940 preferably have a diameter of about 7 mm. Ina further preferred embodiment, as shown for example in FIGS. 8A and 8B,the tenth aspect of the invention further comprises a second viscerallimb 845, 945 attached to the other of the first leg 815, 915 or thesecond leg 820, 920. In this embodiment, the second visceral limb 845,945 can take the form of any embodiment of the first limb 725, 825, 925discussed throughout.

In another preferred embodiment, the first visceral limb 725 is joinedwith one of the first leg 715 or the second leg 720 via passivefixation. In this embodiment, the first visceral limb 725 preferably hasa diameter at the proximal end 726 in a range from about 15 mm to about17 mm and, in various embodiments, may be between about 15-16 mm, 16-17mm or about 15 mm. The diameter at the proximal end 726 of the viscerallimb 725 should be at least about 1 mm larger than the diameter of theleg that receives the limb and the length of the overlap between the legand limb should be at least 30 mm in order for passive fixation to beeffective.

In one passive fixation embodiment, shown in FIGS. 7A, Detail A and 7B,Detail A, the first visceral limb 725 preferably has a length in therange from about 60 mm to about 80 mm and, in various embodiments, maybe between about 60-75 mm, 60-70 mm, 60-65 mm, 60 mm, 65-80 mm, 70-80mm, 75-80 mm or about 80 mm. In a further embodiment, the first viscerallimb 725 may have a bifurcation 730 defining a third leg 735 and afourth leg 740, and the third leg 735 and the fourth leg 740 preferablyeach have a length of about 30 mm. In still another embodiment, each ofthe third leg 735 and the fourth leg 740 preferably have a diameter ofabout 7 mm.

In another passive fixation embodiment, shown in FIGS. 7A, Detail B and7B, Detail B, the first visceral limb 725 preferably has a length in therange from about 60 mm to about 80 mm and, in various embodiments, maybe between about 60-75 mm, 60-70 mm, 60-65 mm, 60 mm, 65-80 mm, 70-80mm, 75-80 mm or about 80 mm. In a further embodiment, the first viscerallimb 725 defines a single lumen 745, and the first visceral limb 725preferably has a diameter at the distal end 746 of about 7 mm.

In a further passive fixation embodiment, shown in FIGS. 7A, Detail Cand 7B, Detail C, the first visceral limb 725 has a length in the rangepreferably from about 70 mm to about 100 mm and, in various embodiments,may be between about 70-95 mm, 70-90 mm, 70-85 mm, 70-80 mm, 70-75 mm,70 mm, 75-100 mm, 80-100 mm, 85-100 mm, 90-100 mm, 95-100 mm or about100 mm. In a further embodiment, the first visceral limb 725 has abifurcation 750 defining a third leg 755 and a fourth leg 760, and thethird leg 755 and the fourth leg 760 preferably each have a length ofabout 30 mm. In yet a further embodiment, the third leg 755 preferablyhas a diameter of about 7 mm and the fourth leg 760 preferably has adiameter of about 16 mm.

Each of the foregoing visceral limb 725 embodiments can be usedinterchangeably with the first or second leg 715, 720 of the debranchingstent graft 700.

In an eleventh aspect, as shown in FIGS. 10A and 10B, the inventionprovides a debranching stent graft 1000 comprising, (a) a main bodystent graft 1005 with a bifurcation 1010 defining a first leg 1015 and asecond leg 1020, wherein the main body stent graft 1050 has a distal end1006 and a proximal end 1007, (b) wherein the main body stent graft 1005has a diameter at the proximal end 1007 in the range from about 28 mm toabout 36 mm, (c) wherein the first leg 1015 and the second leg 1020 eachhave a diameter of about 14 mm, (d) wherein the distance from theproximal end 1007 of the main body stent graft 1005 to the distal end1016 of the first leg 1015 is about 70 mm, (e) and wherein the distancefrom the proximal end 1007 of the main body stent graft 1005 to thedistal end 1021 of the second leg 1020 is about 80 mm.

In various embodiments, the diameter at the proximal end 1007 of themain body 1005 may be between about 28-36 mm, 28-34 mm, 28-32 mm, 28-30mm, 28 mm, 30-36 mm, 32-36 mm, 34-36 mm or about 36 mm.

In one embodiment according to either the tenth or eleventh aspect ofthe invention, the second leg 720, 820, 920, 1020 defines at least onefenestration.

In another embodiment, as shown in FIGS. 10A and 10B, the eleventhaspect further comprises, a first visceral limb 1025 attached to thefirst leg 1015 at the distal end 1006 of the main body stent graft 1005,where the first visceral limb 1025 has a bifurcation 1030 defining athird leg 1035 and a fourth leg 1040, where the bifurcation 1030 occursimmediately at the proximal end 1026 of the first visceral limb 1025,where the first visceral limb 1025 has a length of about 30 mm, andwhere each of the third leg 1035 and the fourth leg 1040 have a diameterof about 7 mm.

In a further embodiment, as shown in FIGS. 10A and 10B, the eleventhaspect further comprises, a visceral extension 1045 joined with thesecond leg 1020, wherein the visceral extension 1045 has a proximal end1046 and a distal end 1047, wherein the visceral extension 1045comprises a tubular main leg 1050 with a bifurcation 1055 defining afirst extension leg 1060 and a second extension leg 1065, wherein thefirst extension leg 1060 has a distal diameter of about 7 mm and thesecond extension leg 1065 has a distal diameter of about 16 mm, andwherein the visceral extension 1045 has a diameter of about 15 mm at theproximal end 1046 and a diameter of about 20 mm at the bifurcation 1055,wherein the visceral extension 1045 has a length of about 93 mm. Invarious embodiments, the length of the visceral extension 1045 may bebetween about 82-199 mm, 87-177 mm, 93-156 mm, 109-140 mm, or about 124mm, about 82 mm, about 156 mm or about 199 mm.

In a twelfth aspect, as shown in FIG. 3, the invention provides a methodfor placement of a debranching stent graft 700, 800, 900 according tothe tenth or eleventh aspect of the invention, comprising (a)introducing a guidewire into the aorta 300 via arterial access, (b)loading a delivery catheter containing a debranching stent graft 700,800, 900 according to the tenth or eleventh aspect of the invention ontothe guidewire, (c) moving the delivery catheter along the guidewire andintroducing the delivery catheter into the aorta via arterial access,(d) and deploying the debranching stent graft 700, 800, 900 into one ofthe aorta 300 or a lumen of a previously-placed stent graft, such as astent graft 100, 200 according to the first or second aspects of theinvention within the aorta 300.

In one embodiment, as shown in FIG. 3, the twelfth aspect furthercomprises, (e) introducing a second guidewire into the aorta 300 viaarterial access, (f) loading a second delivery catheter containing avisceral limb 725, 825, 925 according to the tenth or eleventh aspect ofthe invention onto the second guidewire, (g) moving the second deliverycatheter along the second guidewire and introducing the second deliverycatheter into the first leg 715, 815, 915 or the second leg 720, 820,920 of the debranching stent graft 700, 800, 900 via arterial access,and (h) deploying a proximal end 726, 826, 926 of the visceral limbstent graft 700, 800, 900 into the first leg 715, 815, 915 or the secondleg 720, 820, 920 of the debranching stent graft 700, 800, 900.

In another embodiment, not shown, the twelfth aspect further comprises,(i) introducing a third guidewire into the aorta via arterial access andinto a selected lumen of the debranching stent graft 700, 800, 900, (j)loading a third delivery catheter containing a visceral extension stentgraft 1045 according to the tenth or eleventh aspect of the inventiononto the third guidewire, (k) moving the third delivery catheter alongthe third guidewire and introducing the third delivery catheter into theselected lumen of the debranching stent graft 700, 800, 900 via arterialaccess, and (1) deploying a proximal end 1046 of the visceral extensionstent graft 1045 into the selected lumen of the debranching stent graft700, 800, 900, while the distal end extends into a native vessel.

Debranching Great Vessel Stent Graft and Methods for Use

In a thirteenth aspect, as shown for example in FIGS. 11A-12, theinvention provides a debranching stent graft 1100 comprising, (a) a mainbody stent graft 1105 with a first bifurcation 1110 defining a first leg1115 and a second leg 1120, wherein the main body stent graft 1105 has adistal end 1106 and a proximal end 1107; wherein the main body stentgraft 1105 has a diameter at the proximal end 1106 in the range fromabout 18 mm to about 28 mm, (b) wherein the first leg 1115 and thesecond leg 1120 each have a diameter in the range from about 12 mm toabout 18 mm, (c) wherein the distance from the proximal end 1106 of themain body stent graft 1105 to the distal end 1116 of the first leg 1115is in the range from about 30 mm to about 50 mm, and (d) wherein thedistance from the proximal end 1107 of the main body stent graft 1105 tothe distal end 1121 of the second leg 1120 is in a range from about 50mm to about 70 mm.

Like the debranching visceral stent graft, the debranching great vesselstent graft may be deployed within a lumen of a double-barreled mainbody stent graft as a second level in a debranching procedure or placedin direct contact with a vessel wall as an anchoring main body stentgraft. In addition, the debranching great vessel stent graft could bedeployed in the lumen of any previously-placed appropriately sized stentgraft.

In one preferred embodiment, the diameter of the main body stent graft1105 at the proximal end 1107 is about 25 mm and, in variousembodiments, may be between about 18-28 mm, 20-26 mm, 22-25 mm or 24-25mm. In another preferred embodiment, the first bifurcation 1110 occursin the range from about 20 mm to about 45 mm from the proximal end 1107and, in various embodiments, the distance of the first bifurcation 1110to the proximal end 1107 may be between about 20-50 mm, 25-40 mm, 30-35mm or about 30 mm. In a further preferred embodiment, the first leg 1115and the second leg 1120 each have a diameter of about 14 mm and, invarious embodiments, may be between about 12-18 mm, 13-17 mm, 14-15 mmor 14-16 mm.

In another embodiment, the thirteenth aspect of the invention furthercomprises a first great vessel limb 1125 joined with one of the firstleg 1115 or the second leg 1120 at the distal end 1106 of the main bodystent graft 1105.

In one preferred embodiment shown in FIGS. 11A and 11B, the first greatvessel limb 1125 is joined with one of the first leg 1115 or the secondleg 1120 via a seam 1131. In this embodiment, the first great vessellimb 1125 preferably has a diameter at the proximal end 1126 in therange from about 14-16 mm and, in various embodiments, the diameter atthe proximal end 1126 of the first great vessel limb 1125 may be betweenabout 14-16 mm, 14-15 mm or about 14 mm. Further in this embodiment, thefirst great vessel limb 1125 preferably has a length about 30 mm. Alsoin this embodiment, the first great vessel limb 1125 may have abifurcation 1130 defining a third leg 1135 and a fourth leg 1140, andthe bifurcation 1130 preferably occurs approximately at the seam 1131.Here, each of the third leg 1135 and the fourth leg 1140 preferably havea diameter in the range from about 7 mm to about 12 mm.

In a further preferred embodiment, as shown in FIG. 12, the first greatvessel limb 1225 is again joined with one of the first leg 1215 or thesecond leg 1220 via a seam 1231. In this embodiment, the main body stentgraft 1205 has a diameter at the proximal end 1207 in the range fromabout 20 mm to about 28 mm, where the first bifurcation 1210 occurs inthe range from about 25 mm to about 45 mm from the proximal end 1207 ofthe main body stent graft 1205, and where each of the third leg 1235 andthe fourth leg 1240 have a diameter in the range from about 8 mm toabout 12 mm. In various embodiments, the diameter at the proximal end1207 of the main body stent graft 1205 may be between about 22-26 mm,24-26 mm or about 26 mm. In various embodiments, the distance of thefirst bifurcation 1210 to the proximal end 1207 may be between about20-45 mm, 25-40 mm, 30-35 mm or about 30 mm. In various embodiments, thediameter of each of the third leg 1235 and the fourth leg 1240 may bebetween about 8-11 mm, 9-11 mm, 9-12 mm or about 10 mm. In variousembodiments, the diameter of the second leg 1220 may be between about12-18 mm, 14-16 mm or about 14 mm. In various embodiments the lengthfrom the proximal end 1207 of the main body stent graft 1205 to thedistal end of the second leg 1220 may be between about 55-80 mm, 60-75mm, 60-70 mm, 60-65 mm, 60-80 mm, 65-80 mm, 70-80 mm, 75-80 mm or about60 mm or about 80 mm.

In one embodiment, the thirteenth aspect of the invention furthercomprises a plurality of bi-directional anchor hooks 1245 attached totwo adjacent stents at the proximal end of the main body stent graft1205.

In still another embodiment, the thirteenth aspect of the inventionfurther comprises a radiopaque band 1250 disposed at the distal end ofeach of the first leg 1215, third leg 1235 and fourth leg 1240.

In another embodiment, the main body stent graft 1205 may furtherinclude a directional marker 1255 on the main body stent graft 1205 inany configuration, for example, an “S” shape.

In another preferred embodiment, as shown in FIGS. 13A and 13B, thefirst great vessel limb 1325 is joined with one of the first leg 1115 orthe second leg 1120 via passive fixation. In this embodiment, the firstgreat vessel limb 1325 preferably has a diameter at the proximal end1326 in a range from about 15 mm to about 17 mm and, in variousembodiments, may be between about 15-16 mm, 16-17 mm or about 16 mm. Thediameter at the proximal end 1326 of the great vessel limb 1325 shouldbe at least 1 mm larger than the diameter of the leg that receives thelimb and the overlap between the leg and limb should be at least 30 mmin order for passive fixation to be effective. Further in thisembodiment, the first great vessel limb 1325 preferably has a length inthe range from about 60 mm to about 100 mm and, in various embodiments,may be between about 60-75 mm, 60-70 mm, 60-65 mm or about 60 mm. In onepassive fixation embodiment, the first great vessel limb 1335 has abifurcation 1330 defining a third leg 1335 and a fourth leg 1340, andthe third leg 1335 and the fourth leg 1340 each preferably have a lengthof about 30 mm. In this passive fixation embodiment, each of the thirdleg 1335 and the fourth leg 1340 preferably have a diameter in the rangefrom about 7 mm to about 12 mm. In various embodiments, the length ofthe third leg 1335 may be between about 8-11 mm, 9-11 mm, 9-10 mm orabout 10 mm. In various embodiments, the length of the fourth leg 1340may be between about 7-11 mm, 7-10 mm, 7-9 mm, 7-8 mm or about 7 mm.

In still another embodiment, the thirteenth aspect of the inventionfurther comprises a second great vessel limb attached to the other ofthe first leg 1115 or the second leg 1120. The second great vessel limbcan take the form of any embodiment of the first great vessel limb 1325.In a further embodiment, the second great vessel limb comprises anextension stent graft.

In one embodiment, the second leg 1120 defines at least onefenestration.

In a fourteenth aspect, the invention provides a method for placement ofa debranching stent graft 1100, 1200 according to the thirteenth aspectof the invention, comprising (a) introducing a guidewire into an aortavia arterial access, (b) loading a delivery catheter containing adebranching stent graft 1100 according to the thirteenth aspect of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the aorta viaarterial access, and (d) deploying the debranching stent graft 1100 intoone of the aorta or a lumen of a previously-placed stent graft, such asa stent graft 400 according to the sixth aspect of the invention withinthe aorta.

In one embodiment, the fourteenth aspect further comprises, (e)introducing a second guidewire into the aorta via arterial access, (f)loading a second delivery catheter containing a great vessel limb 1325according to the thirteenth aspect of the invention onto the secondguidewire, (g) moving the second delivery catheter along the secondguidewire and introducing the second delivery catheter into a selectedleg of the debranching stent graft 1100 via arterial access, and (h)deploying a proximal end 1326 of the great vessel limb 1325 into theselected leg of the debranching stent graft 1100, 1200.

In one embodiment, the fourteenth aspect still further comprises, (i)introducing a third guidewire into the descending aorta via arterialaccess and into a selected lumen of the debranching stent graftaccording to the thirteenth aspect of the invention, (j) loading a thirddelivery catheter containing an extension stent graft onto the thirdguidewire, (k) moving the third delivery catheter along the thirdguidewire and introducing the third delivery catheter into the selectedlumen of the debranching stent graft 1100, 1200 via arterial access, and(1) deploying a proximal end of the extension stent graft into theselected lumen of the debranching stent graft 1100, 1200, while thedistal end of the extension stent graft extends into a vessel.

In a fifteenth aspect, the invention provides a method for placement ofa debranching stent graft 1100, 1200 according to the thirteenth aspectof the invention, comprising (a) introducing a guidewire into an aorticarch via arterial access, (b) loading a delivery catheter containing adebranching stent graft 1100, 1200 according to the thirteenth aspect ofthe invention onto the guidewire, (c) moving the delivery catheter alongthe guidewire and introducing the delivery catheter into the aortic archvia arterial access, and (d) deploying the debranching stent graft 1100,1200 into one of the proximal descending aorta or a lumen of apreviously-placed stent graft, such as a stent graft 400 according tothe sixth aspect of the invention within the proximal descending aorta.

In a sixteenth aspect, as shown in FIG. 6, the invention provides amethod for placement of a debranching stent graft 1100, 1200 accordingto the thirteenth aspect of the invention, comprising (a) introducing aguidewire into an ascending aorta via arterial access, (b) loading adelivery catheter containing a debranching stent graft 1100, 1200according to the thirteenth aspect of the invention onto the guidewire,(c) moving the delivery catheter along the guidewire and introducing thedelivery catheter into the ascending aorta via arterial access, and (d)deploying the debranching stent graft 1100, 1200 into one of theascending aorta or a lumen of a previously-placed stent graft, such as astent graft, 400 according to the sixth aspect of the invention withinthe ascending aorta.

In one embodiment, the sixteenth aspect further comprises, (e)introducing a second guidewire into the ascending aorta via arterialaccess and into a selected leg of the debranching stent graft 1100,1200, (f) loading a second delivery catheter containing a great vessellimb 1325 according to the thirteenth aspect of the invention onto thesecond guidewire, (g) moving the second delivery catheter along thesecond guidewire and introducing the second delivery catheter into theselected leg of the debranching stent graft via arterial access, and (h)deploying a proximal end 1326 of the great vessel limb 1325 into theselected leg of the debranching stent graft 1100, 1200.

In one embodiment, the sixteenth aspect still further comprises, (i)introducing a third guidewire into the ascending aorta via arterialaccess and into a selected leg of the debranching stent graft 1100, 1200according to the thirteenth aspect of the invention, (j) loading a thirddelivery catheter containing an extension stent graft according to thethirteenth aspect of the invention onto the third guidewire, (k) movingthe third delivery catheter along the third guidewire and introducingthe third delivery catheter into the selected leg of the debranchingstent graft via arterial access, and (1) deploying a proximal end of theextension stent graft into the selected leg of the debranching stentgraft 1100, 1200, while the distal end of the extension stent graftextends into a great vessel.

Debranching Stent Graft Limb and Methods for Use

The debranching stent graft limbs can be used to exclude a diseasedartery/arteries involving a branched arterial configuration, includingany aneurysm of any anatomical variation or other type of diseasedartery or traumatic injury. The debranching stent graft limbs of theinvention are able to connect to almost any anatomy, and thus provide anease of use in a variety of patients. Deliverance of these debranchingstent graft limbs may be in either an antegrade or retrograde manner,thus allowing approach to almost any diseased artery. When thisdebranching stent graft limb is used in combination with an existingaortic stent graft platform, one non-limiting embodiment may betreatment of common iliac aneurysms in which the stent graft may beoriented within the common iliac artery and the first and secondexpandable prostheses extended into the external and internal iliacarteries, respectively, to maintain pelvic blood flow.

In a seventeenth aspect, as shown in FIGS. 14A and 14B, the inventionprovides a debranching stent graft limb 1400 comprising, (a) a main bodystent graft limb 1405 with a bifurcation 1410 defining a first leg 1415and a second leg 1420, wherein the main body stent graft limb 1405 has adistal end 1406 and a proximal end 1407, (b) wherein the main body stentgraft limb 1405 has a diameter at the proximal end in the range fromabout 14 mm to about 18 mm, (c) wherein the first leg 1415 has adiameter ranging from about 8 mm to about 12 mm, (d) wherein the secondleg 1420 has a diameter ranging from about 6 mm to about 10 mm, and (e)wherein the distance from the proximal end 1407 of the main body stentgraft 1405 to the distal end 1416 of the first leg 1415 and the secondleg 1421 is in the range from about 70 mm to about 90 mm, and whereinthe diameter of the first leg 1415 is about 2 mm greater than thediameter of the second leg 1420.

In one preferred embodiment, the diameter of the first leg 1415 is about10 mm and the diameter of the second leg 1420 is about 8 mm. In variousembodiments, the diameter of the first leg 1415 may be between about8-12 mm, 8-11 mm, 8-10 mm, 9-10 mm, 9-11 mm or 9-12 mm. In variousembodiments, the diameter of the second leg 1420 may be between about6-10 mm, 7-9 mm, 7-8 mm or about 7 mm.

In another preferred embodiment, the diameter of the main body stentgraft limb 1405 at the proximal end 1407 is about 16 mm and, in variousembodiments, may be between 14-18 mm, 15-17 mm or about 16 mm.

In a further preferred embodiment, the distance from the proximal end1407 of the main body stent graft 1405 to the distal end 1416 of thefirst leg 1415 and the second leg 1421 is 80 mm and, in variousembodiments, may be between about 70-90 mm, 70-85 mm, 75-85 mm, or 75-90mm.

In a further preferred embodiment, the distance from the proximal end1407 of the main body stent graft 1405 to the bifurcation 1410 is about40 mm to 60 mm.

In yet another embodiment, the seventeenth aspect further comprises afirst limb expanded within the first leg 1415 and coupled to the firstleg 1415 via passive fixation and a second limb expanded within thesecond leg 1420 and coupled to the second leg 1420 via passive fixation.

In an eighteenth aspect, as shown in FIG. 15, the invention provides amethod for placement of a debranching stent graft limb 1400 according tothe seventeenth aspect of the invention, comprising, (a) introducing aguidewire into any appropriately sized branched arterial configuration1500 via arterial access, (b) loading a delivery catheter containing adebranching stent graft limb 1400 according to the seventeenth aspect ofthe invention onto the guidewire, (c) moving the delivery catheter alongthe guidewire and introducing the delivery catheter into theappropriately sized branched arterial configuration 1500 via arterialaccess, and (d) deploying the debranching stent graft limb 1400 into oneof the appropriately sized branched arterial configuration 1500 and/or alumen of a previously-placed stent graft, such as a stent graftaccording to the tenth, eleventh or thirteenth aspect of the invention.

In one example shown in FIG. 15, a main body stent graft 1510 isanchored in non-diseased tissue of the aorta 1505. A bifurcated stentgraft 1515 is then deployed within the lumen of the main body stentgraft 1510, with one lumen 1516 extending into left common iliac artery1520 and the other lumen 1517 extending within the aneurysmal sac 1506.An extension stent graft 1525 is shown deployed within the lumen 1517within the aneurysmal sac 1506. The debranching stent graft limb 1400 isshown deployed within the extension stent graft 1525 to bridge theaneurysmal sac 1506 and stent the right external iliac artery 1501. Inpractice, an additional extension stent graft (not shown) wouldtypically then be deployed into the right internal iliac artery 1502, asdescribed below.

In one embodiment, as shown in FIG. 15, the eighteenth aspect of theinvention further comprises (e) loading a second delivery cathetercontaining a first limb according to the seventeenth aspect of theinvention onto a proximal end of the guidewire, (f) moving the seconddelivery catheter along the guidewire and introducing the seconddelivery catheter into the first leg 1415 of the debranching stent graftlimb 1400 via arterial access, and (g) deploying a proximal end of thefirst limb into the first leg 1415 of the debranching stent graft limb1400.

In another embodiment, as shown in FIG. 15, the eighteenth aspect of theinvention still further comprises (h) introducing a second guidewireinto the appropriately sized branched arterial configuration through thesecond leg 1420 of a debranching stent limb 1400 according to theseventeenth aspect of the invention via arterial access, (i) loading athird delivery catheter containing a second limb according to theseventeenth aspect of the invention onto the second guidewire, (j)moving the third delivery catheter along the second guidewire andintroducing the third delivery catheter into the second leg 1420 of thedebranching stent graft limb 1400 via arterial access, and (k) deployinga proximal end of the second limb into the second leg 1420 of thedebranching stent graft limb 1400 in the appropriately sized branchedarterial configuration.

In one embodiment, the appropriately sized branched arterialconfiguration comprises the common iliac artery.

In a further embodiment, the invention further comprises placing anaxillary conduit in the exposed artery in the arm. The axillary conduitserves to stabilize the exposed access point of the artery for guidewireand catheter entry. The axillary conduit may be utilized with anyexposed artery access point in any of the methods described herein.

In a nineteenth aspect, the invention provides a method for placement ofa debranching stent graft limb 1400 according to the seventeenth aspectof the invention, comprising, (a) introducing a guidewire into a commoniliac artery via arterial access, (b) loading a delivery cathetercontaining a debranching stent graft limb 1400 according to theseventeenth aspect of the invention onto the guidewire, (c) moving thedelivery catheter along the guidewire and introducing the deliverycatheter into the common iliac artery via arterial access, and (d)deploying the debranching stent graft limb 1400 into one of the commoniliac artery and/or a lumen of a previously-placed stent graft, such asa stent graft according to the tenth, eleventh or thirteenth aspect ofthe invention.

Combination Double-Barreled and Debranching Stent Grafts and Methods forUse

The combination double-barreled and debranching Great vessel main bodystent grafts can be used to treat any aneurysm of any anatomicalvariation or other type of diseased artery or traumatic injury. Thiscombination stent graft may be used in an antegrade deployment in theascending aorta in the normal direction of blood flow. In the antegradedeployment, the proximal portion of the stent graft can be deployedwithin one centimeter of the aortic valve coronary arteries. In thisarrangement, one of the first or second lumens of the combination stentgraft is dedicated to the innominate artery, while the other lumen isdedicated to the left common carotid and the left subclavian arteries.Alternatively, the stent graft may be used in a retrograde deployment inthe aortic arch against the normal direction of blood flow. In theretrograde deployment, the proximal portion of the combination stentgraft can be placed about 11 cm distal to the left subclavian artery. Inthis arrangement, one of the first or second lumens is dedicated to theGreat vessels, while the other lumen is dedicated to the ascendingaorta.

In a twentieth aspect, as shown in FIGS. 16A and 16B, the inventionprovides a stent graft 1600 comprising, (a) a main body stent graft 1605defining a single lumen and having a distal end 1606 and a proximal end1607, (b) a first bifurcation 1610 in the range from about 20 mm toabout 30 mm from the proximal end 1607 of the main body stent graft 1605defining a first lumen 1615 and a second lumen 1620, wherein the mainbody stent graft 1605 defines a tubular wall 1625 that is contiguouswith the first lumen 1615 and the second lumen 1620 such that any fluidentering the main body stent graft 1605 must exit by entering one of thefirst lumen 1615 or the second lumen 1620 , wherein the main body stentgraft 1605 has a diameter at the proximal end 1607 in the range fromabout 40 mm to about 60 mm, wherein the first lumen 1615 and the secondlumen 1620 each have a diameter in the range from about 18 mm to about30 mm, wherein the length from the proximal end 1607 of the main bodystent graft 1605 to the distal end 1621 of the second lumen 1620 is inthe range from about 70 mm to about 90 mm, (c) a second bifurcation 1630within the second lumen 1620 about 30 mm from the distal end 1621 of thesecond lumen 1620 defining a first leg 1635 and a second leg 1640,wherein the first leg 1635 and the second leg 1640 each have a diameterin the range from about 14 mm to about 16 mm, and (d) a thirdbifurcation 1645 within the second leg 1640 about 20 mm to 30 mm distalfrom the second bifurcation 1630 defining a third leg 1650 and a fourthleg 1655, wherein the third leg and the fourth leg each have a diameterin the range from about 7 mm to about 12 mm, wherein the third leg 1650and fourth leg 1655 each have a length in the range from about 20 mm toabout 30 mm.

In one embodiment of the twentieth and the twenty-first aspects, thecombination double-barreled and debranching main body stent graft 1600,1700 can be made by joining a debranching stent graft to the completeperiphery of a distal end of an existing single lumen main body stentgraft and then optionally joining the first lumen 1615 and the secondlumen 1620 to one another along a shared length. The main body stentgraft can be joined with a debranching stent graft using adhesive,sewing, bonding, or welding, or any other known mechanism, for example.The same means can be used to join the two single lumens along a sharedlength 1660. Alternatively, the main body stent graft and thedebranching stent graft could be manufactured as a single unitary stentgraft. These mechanisms for joining, securing or attaching stent graftcomponents together prior to in vivo deployment can be used with any ofthe aspects for the double-barreled stent grafts, debranching stentgrafts or debranching stent graft limbs disclosed herein.

In one preferred embodiment, the main body stent graft 1605 has adiameter at the proximal end 1606 of about 40 mm and, in variousembodiments, may be between about 40-60 mm, 45-55 mm, about 50 mm, about60 mm or about 40 mm. In another preferred embodiment, the first lumen1615 has a diameter of about 20 mm and, in various embodiments, may bebetween about 18-30 mm, 20-28 mm, 22-26 mm or 24 mm. In a furtherpreferred embodiment, the second lumen 1620 has a diameter in the rangefrom about 18 mm to about 20 mm and, in various embodiments, may bebetween about 18-30 mm, 20-28 mm, 22-26 mm or about 24 mm. In yetanother preferred embodiment, the length from the proximal end 1607 ofthe main body stent graft 1605 to the distal end 1621 of the secondlumen 1620 is about 70 mm and, in various embodiments, may be betweenabout 70-90 mm, 70-85 mm, 70-80 mm, 70-75 mm, 70 mm, 75-90 mm, 80-90 mm,85-90 mm or about 90 mm. In various embodiments, each of the diametersof the first leg 1635 and the second leg 1640 may be between about 14-16mm, 14-15 mm, 15-16 mm or about 14 mm. In various embodiments, the thirdleg 1650 and the fourth leg 1655 each have a diameter in the range fromabout 7 mm to about 12 mm and, in various embodiments, may be betweenabout 7-12 mm, 8-11 mm, 9-10 mm or about 10 mm. In a preferredembodiment, the third leg 1650 and fourth leg 1655 each have a length ofabout about 30 mm.

In another preferred embodiment of the twentieth and the twenty-firstaspects, the first lumen and the second lumen each retain asubstantially cylindrical profile. In one embodiment, a cylindricalstent structure is disposed on an exterior of the main body stent graftto aid the first and second lumens in maintaining a substantiallycylindrical profile.

In one embodiment, the first lumen 1615 is secured to the second lumen1620 along a shared length of about 30 mm. In another embodiment of thetwentieth and the twenty-first aspects, the first lumen 1615 and thesecond lumen 1620 are secured together along the shared length 1660 viaone or more of stitching, adhesive, or bonding. The two lumens aresecured together in a manner that does not substantially deform thecylindrical shape of the lumens. This embodiment is equally applicableto any aspects of the double-barreled stent grafts and debranching stentgrafts, especially when a given stent graft is intended for use as ananchoring main body stent graft.

In another embodiment, as shown in FIGS. 17A and 17B, the twentieth andthe twenty-first aspect further comprise a fixation stent 1765 affixedto the proximal end 1707 of the main body stent graft 1705. Thisembodiment is equally applicable to any aspects of the double-barreledstent grafts and debranching stent grafts, especially when a given stentgraft is intended for use as an anchoring main body stent graft.

In a twenty-first aspect, as shown in FIGS. 17A and 17B, the inventionprovides a stent graft 1700 comprising, (a) a main body stent graft 1705defining a single lumen and having a distal end 1706 and a proximal end1707, (b) a first bifurcation 1710 in the range from about 20 mm toabout 30 mm from the proximal end 1707 of the main body stent graft 1705defining a first lumen 1715 and a second lumen 1720, wherein the mainbody stent graft 1705 has a diameter at the proximal end 1707 in therange from about 40 mm to about 60 mm, wherein the first lumen 1715 hasa diameter in the range from about 20 mm to about 30 mm at the firstbifurcation 1710 and has a diameter in the range from about 20 mm to 40mm at the distal end 1716 of the first lumen 1715, wherein the firstlumen 1715 has a length from about 50 mm to about 150 mm from the firstbifurcation 1710 to the distal end 1716 of the first lumen 1715, whereinthe second lumen 1720 has a diameter in the range from about 20 mm toabout 30 mm at the first bifurcation 1710, (c) a second bifurcation 1730within the second lumen 1720 about 30 mm from the distal end 1721 of thesecond lumen 1720 defining a first leg 1735 and a second leg 1740,wherein the first leg 1735 and the second leg 1740 each have a diameterin the range from about 14 mm to about 16 mm, wherein the length fromthe proximal end 1707 of the main body stent graft 1705 to the distalend 1741 of the second lumen's second leg 1740 is in the range fromabout 50 mm to about 70 mm, and (d) a third bifurcation 1745 within thefirst leg 1735 that defines a third leg 1750 and a fourth leg 1755,wherein the third leg 1750 and the fourth leg 1755 each have a diameterof about 7 mm to about 12 mm, wherein the third leg 1750 and fourth leg1755 each have a length in the range from about 20 mm to about 30 mm.

In various embodiments, the diameter at the proximal end 1706 of themain body stent graft 1705 may be between about 40-60 mm, 40-55 mm,40-50 mm, 40-45 mm, 45-55 mm, 45-60 mm, 50-60 mm, 55-60 mm, about 50 mm,about 60 mm or about 40 mm. In various embodiments, the first lumen 1715has a diameter in the range from about 20 mm to 40 mm at the distal end1716 of the first lumen 1715 and, in various embodiments, may be betweenabout 21-45 mm, 22-40 mm, 23-35 mm, 24-30 mm or about 24 mm. In variousembodiments, the length from the proximal end 1707 of the main bodystent graft 1705 to the distal end 1721 of the second lumen 1720 may bebetween about 50-70 mm, 50-65 mm, 50-60 mm, 50-55 mm, 50 mm, 55-70 mm,60-70 mm, 55-70 mm or about 70 mm. In various embodiments, each of thediameters of the first leg 1735 and the second leg 1740 may be betweenabout 14-16 mm, 14-15 mm, 15-16 mm or about 14 mm. In variousembodiments, the third leg 1750 and the fourth leg 1755 each have adiameter in the range from about 7 mm to about 12 mm and, in variousembodiments, may be between about 8-11 mm, 9-10 mm or about 10 mm. In apreferred embodiment, the third leg 1650 and fourth leg 1655 each have alength of about 30 mm.

In one preferred embodiment, the main body stent graft 1705 defines atubular wall 1725 that is contiguous with the first lumen 1715 and thesecond lumen 1720 such that any fluid entering the main body stent graft1705 must exit by entering one of the first lumen 1715 or the secondlumen 1720. This tubular wall 1725 forms a complete seal with the aorticwall.

In one embodiment, the first lumen 1715 is secured to the second lumen1720 along a shared length 1760 from the first bifurcation 1710 to thethird bifurcation 1745.

In one embodiment, shown in FIG. 18, the twentieth and/or thetwenty-first aspects further comprise a stent valve 1800 affixed to theproximal end 1707 of the main body stent graft 1705, where a free end1801 of the stent valve 1800 is covered and a portion of the stent valve1802 extending between the free end 1801 and the proximal end 1707 ofthe main body stent graft 1705 is uncovered. In this embodiment, thefree covered end 1801 of the stent valve 1800 lies in the aortic outflowtract 1805, while the uncovered portion 1802 of the stent valve 1800lays across the coronary arteries 1810 permitting blood flow to continuein a normal manner.

In a twenty-second aspect, the invention provides a method for placementof a stent graft 1600, 1700 according to one of the twentieth ortwenty-first aspects of the invention, comprising, (a) introducing aguidewire into a thoracic aorta via arterial access, (b) loading adelivery catheter containing a stent graft 1600, 1700 according to oneof the twentieth or twenty-first aspects of the invention onto theguidewire, (c) moving the delivery catheter along the guidewire andintroducing the delivery catheter into the thoracic aorta via arterialaccess, and (d) deploying the stent graft 1600, 1700 into the thoracicaorta.

In a twenty-third aspect, the invention provides a method for placementof a stent graft 1600, 1700 according to one of the twentieth,twenty-first or twenty-fifth aspects of the invention, comprising, (a)introducing a guidewire into an aorta via arterial access, (b) loading adelivery catheter containing a stent graft 1600, 1700 according to oneof the twentieth, twenty-first or twenty-fifth aspects of the inventiononto the guidewire, (c) moving the delivery catheter along the guidewireand introducing the delivery catheter into the aorta via arterialaccess, and (d) deploying the stent graft 1600, 1700 into the aorta.

In one embodiment, the twenty-third aspect of the invention furthercomprises, (a) introducing a second guidewire into the aorta viaarterial access, (b) loading a second delivery catheter containing anextender stent graft onto the second guidewire, (c) moving the seconddelivery catheter along the second guidewire and introducing the seconddelivery catheter into a leg or a lumen of the stent graft via arterialaccess, and (d) deploying a proximal end of the extender stent graftinto the leg or the lumen of the stent graft.

In a twenty-fourth aspect, as shown in FIG. 18, the invention provides amethod for placement of a stent 1600, 1700 according to one of thetwentieth or twenty-first aspects of the invention, comprising, (a)introducing a guidewire into an ascending aorta 1800 via arterialaccess, (b) loading a delivery catheter containing a stent graft 1600,1700 according to one of the twentieth or twenty-first aspects of theinvention onto the guidewire, (c) moving the delivery catheter along theguidewire and introducing the delivery catheter into the ascending aorta1800 via arterial access, and (d) deploying the stent graft 1600, 1700into the ascending aorta 1800.

In a twenty-fifth aspect, as shown in FIGS. 19A and 19 B, the inventionprovides stent graft 1900 comprising (a) a main body stent graft 1905defining a single lumen and having a distal end 1906 and a proximal end1907, (b) a first bifurcation 1910 in the main body stent graft 1905defining a first lumen 1915 and a second lumen 1920, where the main bodystent graft 1905 defines a tubular wall 1925 that is contiguous with thefirst lumen 1915 and the second lumen 1920 such that any fluid enteringthe main body stent graft 1905 must exit by entering one of the firstlumen 1915 or the second lumen 1920, where the main body stent graft1905 has a diameter at the proximal end 1907 in the range from about 28mm to about 42 mm, where the first lumen 1915 has a diameter in therange from about 22 mm to about 28 mm and the second lumen 1920 has adiameter in the range from about 16 mm to about 22 mm, (c) a secondbifurcation 1930 within the first lumen 1915 defining a first leg 1935and a second leg 1940, where the first leg 1935 and the second leg 1940each have a diameter in the range from about 14 mm to about 16 mm, (d) athird bifurcation 1945 within the first leg 1935 about 0 mm to about 10mm distal from the second bifurcation 1930 defining a third leg 1950 anda fourth leg 1955, where the third leg 1950 and the fourth leg 1955 eachhave a diameter in the range from about 7 mm to about 12 mm, where thethird leg 1950 and the fourth leg 1955 each have a length in the rangefrom about 30 mm to about 50 mm, and (e) a fourth bifurcation 1960within the second leg 1940 between about 10 mm and about 20 mm distalfrom the second bifurcation 1930 defining a fifth leg 1965 and a sixthleg 1970, where the fifth leg 1965 and the sixth leg 1970 each have adiameter in the range from about 7 mm to about 12 mm, where the fifthleg 1965 and the sixth leg 1970 each have a length in the range fromabout 30 mm to about 50 mm.

In various embodiments, the main body stent graft 1905 has a diameter atthe proximal end 1907 in the range between about 28-40 mm 28-38 mm,28-36 mm, 28-34 mm, 28-32 mm, 28-30 mm, 30-42 mm, 32-42 mm, 34-42 mm,36-42 mm, 38-42 mm, 40-42 mm, about 28 mm, and about 42 mm.

In one preferred embodiment, the first lumen 1915 has a diameter ofabout 22 mm and, in various embodiments, may be between about 22-28 mm,22-27 mm, 22-26 mm, 22-25 mm, 22-24 mm, or 22-23 mm.

In various embodiments, the second lumen 1920 has a diameter betweenabout 16-17 mm, 16-18 mm, 16-19 mm, 16-20 mm, 16-21 mm, 17-22 mm, 18-22mm, 19-22 mm, or 21-22 mm.

In yet another preferred embodiment, the length from the proximal end1907 of the main body stent graft 1905 to the distal end 1921 of thesecond lumen 1920 is in the range from about 100 mm to about 200 mm and,in various embodiments, may be between about 110-200 mm, 120-200 mm,130-200 mm, 140-200 mm, 150-200 mm, 160-200 mm, 170-200 mm, 180-200 mm,190-200 mm, 100-190 mm, 100-180 mm, 100-170 mm, 100-160 mm, 100-150 mm,100-140 mm, 100-130 mm, 100-120 mm, or 100-110 mm. In a furtherpreferred embodiment, the length from the proximal end 1907 of the mainbody stent graft 1905 to the distal end 1921 of the second lumen 1920 isabout 150 mm.

In another preferred embodiment, the first bifurcation 1910 occurs inthe range from about 20 mm to about 30 from the proximal end 1907 of themain body stent graft 1905 and, in various embodiments, may be betweenabout 20-28 mm, 20-26 mm, 20-25 mm, 20-24 mm, 20-22 mm, 22-30 mm, 24-30mm, 25-30 mm, 26-30 mm, or 28-30 mm.

In a further preferred embodiment, the second bifurcation 1930 occurs inthe range from about 30 mm to about 60 mm from the proximal end 1907 ofthe main body stent graft 1905 and, in various embodiments, may bebetween about 30-55 mm, 30-50 mm, 30-45 mm, 30-40 mm, 30-35 mm, 35-60mm, 40-60 mm, 45-60 mm, 50-60 mm, or 55-60 mm.

In various other embodiments, the first leg 1935 and the second leg 1940each have a diameter between about 14-15 mm, 15-16 mm, about 14 mm orabout 16 mm

In various embodiments, the third bifurcation 1945 occurs within thefirst leg 1935 between about 0-8 mm 0-6 mm, 0-4 mm, 0-2 mm 2-10 mm, 4-10mm, 6-10 mm, 8-10 mm, about 0 mm or about 10 mm distal from the secondbifurcation 1930.

In a preferred embodiment, the third leg 1950 and the fourth leg 1955each have a diameter of about 7 mm and, in various other embodiments,between about 7-11 mm, 7-10 mm, 7-9 mm, 7-8 mm, 8-12 mm, 9-12, 10-12 mmor 11-12 mm. In various other embodiments, the third leg 1950 and thefourth leg 1955 each have a length between about 30-45, 30-40 mm, 30-35mm, 35-50 mm, 40-50 mm or 45-50 mm.

In various embodiments, the a fourth bifurcation 1960 occurs within thesecond leg 1940 between about 10-12 mm, 10-14 mm, 10-16 mm, 10-18 mm,12-20 mm, 14-20 mm, 16-20 mm, or 18-20 mm distal from the secondbifurcation 1930.

In a preferred embodiment, the fifth leg 1965 and the sixth leg 1970each have a diameter of about 7 mm and, in various other embodiments,between about 7-11 mm, 7-10 mm, 7-9 mm, 7-8 mm, 8-12 mm, 9-12, 10-12 mmor 11-12 mm. In various other embodiments, the fifth leg 1965 and thesixth leg 1970 each have a length between about 30-45, 30-40 mm, 30-35mm, 35-50 mm, 40-50 mm or 45-50 mm.

In a preferred embodiment, the main body stent graft 1905, the firstlumen 1915, the second lumen 1920, the first leg 1935, the second leg1940, the third leg 1950, the fourth leg 1955, the fifth leg 1965 andthe sixth leg 1970 comprise a single unitary structure. This unitarystructure can be achieved via one or more of a common graft covering,stitching, adhesive, bonding, welding or any other technique known inthe art. Moreover, in one preferred embodiment, the first lumen 1915 andthe second lumen 1920 are attached to the distal end 1906 of the mainbody stent graft 1905 via one of a common graft covering, stitching,adhesive, bonding, or welding. In another embodiment, the first leg 1935and the second leg 1940 are attached to the distal end 1916 of the firstlumen 1915 via one of a common graft covering, stitching, adhesive,bonding, or welding. In a further embodiment, the third leg 1950 and thefourth leg 1955 are attached to the distal end 1936 of the first leg1935 via one of a common graft covering, stitching, adhesive, bonding,or welding. In yet another embodiment, the fifth leg 1965 and the sixthleg 1970 are attached to the distal end 1941 of the second leg 1940 viaone of a common graft covering, stitching, adhesive, bonding, orwelding.

In still a further embodiment, the first lumen is secured to the secondlumen along a shared length. In this embodiment, the first lumen 1915and the second lumen 1920 may be secured together along the sharedlength via one or more of a common graft covering, stitching, adhesive,bonding or welding.

In one preferred embodiment, the first lumen 1915 and the second lumen1920 each retain a substantially cylindrical profile to maintain acomplete seal with the aortic wall. In another embodiment, thecombination double-barreled and debranching stent graft 1900 furtherincludes a cylindrical stent graft structure (not shown), discussed indetail with respect to the sixth aspect of the invention, on an exteriorof the main body stent graft 1905.

In another preferred embodiment, discussed in detail with respect to thetwentieth and twenty-first aspects of the invention, the stent graftfurther includes a stent valve affixed to the proximal end 1906 of themain body stent graft 1905, wherein a free end of the stent valve iscovered and a portion of the stent valve extending between the free endand the main body stent graft 1905 is uncovered.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement that is calculated to achieve the same purpose maybe substituted for the specific embodiments shown. This application isintended to cover any adaptations or variations of embodiments of thepresent invention. It is to be understood that the above description isintended to be illustrative, and not restrictive, and that thephraseology or terminology employed herein is for the purpose ofdescription and not of limitation. The above embodiments and otherembodiments may be combined as is apparent to those of skill in the artupon studying the above description, unless noted otherwise. Forexample, each of the aspects drawn to double-barreled stent grafts couldbe deployed within any of the debranching stent grafts. Likewise, any ofthe debranching stent graft limbs could be deployed within any of thedebranching stent grafts. The scope of the present invention includesany other applications in which embodiment of the above structures anddeployment methods are used. The scope of the embodiments of the presentinvention should be determined with reference to claims associated withthese embodiments, along with the full scope of equivalents to whichsuch claims are entitled.

As used herein, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. “And” as usedherein is interchangeably used with “or” unless expressly statedotherwise.

All embodiments within and between different aspects of the inventioncan be combined unless the context clearly dictates otherwise.

EXAMPLE 1 Endovascular De-branching of a Thoraco-Abdominal Aneurysm

The ultimate vascular procedure is the open repair of the ThoracicAbdominal Aneurysm (TAA). The undertaking of such a procedure, is achallenge for the surgeon, surgical team, the institution where theseprocedures are performed, but none of this compares to the challenge thepatient and their family endures to recover from such an invasiveprocedure.

There have been several surgical approaches to this procedure. There areonly a few sites in the country that can offer an open TAA repair withacceptable complication rates. A newer surgical approach isde-branching, with either concurrent or delayed stenting. This approachmay have reduced many of the major complication rates but has its ownother major complications. Any surgeon performing this surgeryunderstands that this is a very arduous surgery and the patient has avery challenging recovery. A fenestrated stent grafting is newer, lessinvasive method for repair of the TAA. These custom made grafts areeither constructed on the back table in the operating room or specialorder. These are technically very challenging cases that are performedat a select number of centers.

A minimally invasive debranching of the TAA via bilateral femoral andone axillary artery exposure was recently performed:

A visceral double barreled main body stent graft was constructed, withone barrel dedicated to stent the visceral segment, while the otherbarrel was dedicated to the revascularization of the infra-renal aorta.

A visceral graft was constructed by modifying a standard bifurcatedstent graft. Modifications were made to the ipsilateral andcontralateral limbs of the stent graft. Two 6 mm self-expandable coveredstents were sewn to the ipsilateral limb and two 7 mm self-expandablecovered stents were sewn to the contralateral limb. The newlyconstructed debranching visceral stent graft was re-sheathed byconstraining the debranching visceral stent graft with spirally wrappingwire around the stent graft's exterior.

The visceral double-barreled stent graft and debranching visceral stentgraft were re-sheathed. The visceral double-barreled stent graft wasthen positioned and deployed within the thoracic aorta. The debranchingvisceral stent graft was then positioned and deployed within a lumen ofthe visceral double-barreled main body stent graft, with the distalpoint of the debranching visceral stent graft about 4 cm above theosteol of the celiac artery.

From an arm approach (axillary artery with a conduit), individualselection of each renal artery was possible from one of the two 6 mmcovered stents. Covered extension stent grafts were deployed from thedebranching visceral stent graft to each renal artery. The sametechnique was used for the superior mesenteric artery (“SMA”) and celiacartery through the 7 mm stent graft off of the short leg of thedebranching visceral stent graft. With the visceral segment de-branched,we extended the open barrel of the visceral double-barreled main bodystent graft to an infra-renal position, and the remaining part of thesurgery was a standard infra-renal endovascular aortic repair (“EVAR”).

The advantage of such an approach allows a less invasive approach to avery challenging surgical problem. The present invention provides a muchmore versatile approach that can handle an almost infinite anatomicconfigurative without customized graft construction.

EXAMPLE 2 Endovascular De-branching of a Thoraco-Abdominal Aneurysm

Endovascular repair of infra-renal abdominal aneurysms has become anaccepted alternative to traditional open surgical repair. Thesetechniques allow for shorter hospital stays following a less invasiveprocedure and initially reduced morbidity and mortality in patients.However, endovascular repair using stent grafts has been slow toovertake open surgical repair as the standard treatment forthoracoabdominal aortic aneurysms (TAA) due to anatomical restrictionsand the high cost of custom stent grafts to accommodate individualaneurysm cases. The case presented here represents a method ofendoluminal repair of TAA.

With the patient under general anesthesia, standard groin and rightaxillary incisions were made, exposing the vessels. This allowed theright/left common femoral arteries to be accessed with a 5 French sheathand measuring pigtail catheter to allow for angiograms to be performedto define the patient's specific anatomy. At this point, two grafts wereconstructed. One was a visceral double-barreled main body stent graftand the other was a debranching visceral stent graft. The visceraldouble-barreled main body stent graft was constructed from a 100 mmthoracic stent graft by sewing a seam vertically up the graft for 70 mm,thus creating a double-barrel configuration. The debranching visceralstent graft was made from a standard main body bifurcated graft with twoself-expanding covered stent grafts sewn to each limb; this created atotal of four stents staggered two proximal and two distal to theipsilateral and contralateral limbs. Once sewn, the debranching visceralstent graft was re-constrained using 20 gauge surgical wire andre-sheathed. During this process, care was taken to maintain theorientation markers.

The visceral double-barreled stent graft was placed approximately 11 cmabove the celiac artery. The debranching visceral stent graft was theninserted through the lumen of one of the barrels of the visceral doublebarrel stent graft, with approximately 4-5 cm of overlap. The distalvisceral limbs were placed 4 cm above the celiac artery to allowadequate room for cannulation of the visceral segment vessels.

A 10-mm Dacron graft was sewn as a conduit off the right axillary arteryallowing access through a sheath to the descending aorta. The openbarrel of the visceral double-barreled main body stent graft wasselected for the pigtail catheter placement and eventually for theinfrarenal segment. An 8-mm long French sheath was brought in from theaxillary conduit. Through the individual limbs of the debranchingvisceral stent graft, the celiac, SMA, and renal arteries were stented.Upon stenting of four visceral arteries, the open barrel of the visceraldouble-barreled main body stent graft was extended to an infrarenalposition using a straight thoracic stent graft. At this point, astandard infrarenal endoluminal abdominal aortic aneurysm repair wasperformed.

Throughout the procedure, the patients were heparinized and stent-graftcontact points were angioplastied. Completion angiograms were performedand the right axillary conduit was oversewn. The patients were protectedwith a lumbar drain in the usual manner with special attention toadequate spinal perfusion via control of spinal fluid pressures and meanarterial pressures.

Following the procedure, the patients were transferred to the ICU forclose monitoring with a spinal drain in place. The spinal drain remainedin place for 48-72 hours and upon its removal the patients were advancedto normal activity. By the fourth day of the hospital stay, they weredoing well, remained neurologically intact and were getting ready fordischarge. One month follow up revealed the patients were doing well.

The conventional open thoracoabdominal approach for handlingthoracoabdominal aneurysms is challenging for all involved includingsurgical staff, post-surgery nursing staff and especially the patients.Significant complications of the open approach can include paraplegia,renal failure, and death. This has led to the exploration and acceptanceof other techniques.

Open debranching followed by either concurrent or delayed stent-graftinghas been performed and been shown to be successful with some reductionin complication rates. However, these remain arduous surgeries for staffand patients with significant complications. Newer techniques usingfenestrated grafts are on the horizon. Unfortunately, these newermethods are geared towards juxtarenal aneurysms. Classicthoracoabdominal aneurysms extending from the mid thoracic more distallyare still seldom approachable endovascularly by current technologies.

In the cases above, a complete endo-debranching was performed, whichdemonstrates the application of a viable alternative which preservesvisceral and infrarenal blood flow with minimal insult to the patient.The advantages of this approach are its versatility with regards toanatomical variations and its inherent redundancies with regard todealing with challenges through the operative procedure.

EXAMPLE 3 Endovascular De-branching of a Thoracic Aneurysm

The patient is a 47-year-old female who presented with a symptomaticthoracic dissection with large thoracic aneurysm, type A dissection,with unfortunate significant aneurysmal changes throughout the entirelength down into her iliac artery. Her visceral segment came off of atrue lumen.

The patient was placed in a supine position and the neck, chest, arms,and groins were prepped and draped in a normal sterile manner. The leftcommon, internal and external carotid arteries were dissected out with alongitudinal incision in a standard manner and circumferentiallycontrolled. A longitudinal incision was made over the brachial arteryand dissected down to the left brachial artery with circumferentialcontrol. A vertical incision was made in both the right and left groin,dissected down to the common femoral, deep femoral, and superficialfemoral arteries with circumferential control. The focus then shifted tothe patient's right side where a transverse supraclavicular incision wasmade and dissection was carried down to the subclavian artery which wasexposed proximally and distally.

At this point, the patient was heparinized. A 10-mm conduit was sewnonto the subclavian artery in an end-to-side manner. Once the conduithad adequate hemostasis, access was gained to the right common femoralartery and left common femoral artery with a pigtail catheter placed upinto the aortic arch, from right common femoral artery access. Wires andcatheters were placed from the left brachial artery, as well as from theleft common carotid artery. Care was taken to select true lumen with thedissection in the left common carotid artery. This was done withultrasound guidance, and wires were placed in the ascending aorta fromthe access points.

With the wires in place, the focus shifted to the aortic archdouble-barreled main body stent graft, which was created by modificationof a 40-mm Valiant stent graft on the back table prior to induction.This aortic arch double-barreled main body stent graft was thenpositioned in the correct orientation from right subclavian arteryaccess and deployed, with a guidewire in one of the double-barrellumens. The deployment was performed with holding respirations and withrapid pacing. The right common femoral artery was then used as theaccess point to select the other double-barrel lumen of the stent graft.

From here, we once again moved back to the right subclavian arteryaccess and positioned and deployed the debranching Great vessel stentgraft. This stent graft was modified from a standard main body 20-mmgraft on the back table prior to induction. The individual legs/limbs ofthe debranching Great vessel stent graft were then selected retrogradefrom the left common carotid artery and from the left subclavian artery.

Intravascular ultrasound (“IVUS”) was introduced to verify correct lumenselection. The left subclavian access was in the incorrect lumen. So anOmni Flush catheter was used from the right subclavian artery toretrograde select the subclavian Viabahn branch in an up-and-overtechnique. From the left subclavian, this wire was then snared. In athrough-and-through manner, a wire was passed into the dedicated 10-mmViabahn limb of the debranching Great vessel stent graft. This was thenconfirmed with IVUS. iCAST 10-mm stents were then used to stent from thedebranching Great vessel stent graft to the subclavian artery on theleft side. This stent graft was smoothed out with a 14×60 self-expandingstent.

Then an 18×150 thoracic stent graft extender was brought from the rightcommon femoral artery up and over a very steep aortic arch forplacement. This pushed the aortic arch double-barreled main body stentgraft (without a stent valve attached) down towards the coronaryarteries. The patient remained stable through this process. Balloonswere placed from both the arm and the groin into the double-barrellumens and the main body. The aortic arch double-barreled main bodystent graft was repositioned back up into the correct location. At thispoint, a 16×20×82 innominate stent graft was placed from the innominateportion of the debranching Great vessel stent graft into the innominateartery. This was extended with a 23-mm Gore cuff and demonstrated goodblood flow. The position was then re-locked with the balloon in theproximal portion of this stent graft and the 18×150 thoracic stent graftextender was re-advanced and positioned in a lumen of the aortic archdouble-barrel main body stent graft and through the aortic arch. Anadditional 30×150 stent graft extender was placed within the thoracicstent graft extender and contact points were angioplastied.

From here, the connection between the left common carotid and thedebranching Great vessel stent graft was completed with 10 mm iCASTstent grafts. These were smoothed out with 12 and 14 mm self-expandingstents. The thoracic aortic arch was completely debranched with goodflows and equal pressures in both artery lines, right and left.

Next an angiogram was performed on the infrarenal aorta. A dissectionwas identified into the left common iliac artery. This was then excludedusing kissing 16 mm stent grafts extending from the distal aorta intothe common iliac artery right to the internal iliac bilaterally, andthese points were angioplastied with very good results, and dopplerablesignals.

The catheter, wires, and sheaths were removed. The brachial artery onthe left side was closed with interrupted 7-0 Prolenes. The left commoncarotid sheath site was closed with interrupted 6-0 Prolene. The rightsubclavian conduit was stapled off with an Endo GIA stapler. The groinartery sheaths were removed and these were closed with interrupted 4-0Prolenes. With adequate hemostasis at all sites, the patient'sheparinization was reversed.

The incisions were irrigated and closed in layers in a standard manner.The neck incision was reapproximated with running Vicryl and drains wereplaced in both neck incisions. The subclavian incision on the right sidewas also sewn with Vicryl, while the arm incision on left and the groinincisions were closed with staples.

Angiographic findings demonstrated a patent aortic arch, patent Greatvessels with a very large dissection and aneurysmal changes. After stentgrafting as described above, there was retained flow to the rightinnominate, the right common carotid, the left common carotid, the leftsubclavian, as well as the vertebral arteries. There was also retainedflow to the descending aorta and the distal segment with retained flowto the lower extremity, common iliac arteries, internal and externaliliac arteries. There was still faint filling of the dissection.

We claim:
 1. A stent graft comprising: a main body stent graft defininga single lumen; a first bifurcation in the main body stent graftdefining a first lumen and a second lumen; a second bifurcation withinthe first lumen defining a first leg and a second leg; a thirdbifurcation within the first leg defining a third leg and a fourth leg;and a fourth bifurcation within the second leg distal to the secondbifurcation defining a fifth leg and a sixth leg, wherein the main bodystent graft, the first lumen, the second lumen, the first leg, thesecond leg, the third leg, the fourth leg, the fifth leg and the sixthleg comprise a single unitary structure.
 2. The stent graft of claim 1,wherein the main body stent graft has a diameter at a proximal end inthe range from about 28 mm to about 42 mm.
 3. The stent graft of claim1, wherein a length from a proximal end of the main body stent graft toa distal end of the second lumen is in the range from about 100 mm toabout 200 mm.
 4. The stent graft of claim 1, wherein the firstbifurcation occurs in the range from about 20 mm to about 30 mm from aproximal end of the main body stent graft.
 5. The stent graft of claim1, wherein the second bifurcation occurs in the range from about 30 mmto about 60 mm from a proximal end of the main body stent graft.
 6. Thestent graft of claim 1, wherein the third bifurcation occurs about 0 mmto about 10 mm distal to the second bifurcation.
 7. The stent graft ofclaim 1, wherein the first lumen has a diameter in the range from about22 mm to about 28 mm and the second lumen has a diameter in the rangefrom about 16 mm to about 22 mm.
 8. The stent graft of claim 1, whereinthe third leg, the fourth leg, the fifth leg and the sixth leg each havea diameter in the range from about 7 mm to about 12 mm.
 9. The stentgraft of claim 1, wherein the first leg and the second leg each have adiameter in the range from about 14 mm to about 16 mm.
 10. The stentgraft of claim 1, wherein the first lumen and the second lumen eachretain a substantially cylindrical profile.
 11. The stent graft of claim1, wherein the main body, the first lumen, the second lumen, the firstleg, the second leg, the third leg, the fourth leg, the fifth leg andthe sixth leg comprise a single unitary structure.
 12. The stent graftof claim 1, wherein the first lumen and the second lumen are attached tothe distal end of the main body via one of a common graft covering,stitching, adhesive, bonding, or welding.
 13. The stent graft of claim1, wherein the first leg and the second leg are attached to the distalend of the first lumen via one of a common graft covering, stitching,adhesive, bonding, or welding.
 14. The stent graft of claim 1, whereinthe third leg and the fourth leg are attached to the distal end of thefirst leg via one of a common graft covering, stitching, adhesive,bonding, or welding, and wherein the fifth leg and the sixth leg areattached to the distal end of the second leg via one of a common graftcovering, stitching, adhesive, bonding, or welding.
 15. The stent graftof claim 1, wherein the first lumen is secured to the second lumen alonga shared length.
 16. The stent graft of claim 13, wherein the firstlumen and the second lumen are secured together along the shared lengthvia one or more of a common graft covering, stitching, adhesive, bondingor welding.
 17. The stent graft of claim 1, further comprising: acylindrical stent structure disposed on an exterior of the main bodystent graft.
 18. The stent graft of claim 1, further comprising: a stentvalve affixed to the proximal end of the main body stent graft, whereina free end of the stent valve is covered and a portion of the stentvalve extending between the free end and the main body stent graft isuncovered.
 19. A method for placement of a stent graft, the methodcomprising: introducing a guidewire into an aorta via arterial access;loading a delivery catheter containing a stent graft according to claim1 onto the guidewire; moving the delivery catheter along the guidewireand introducing the delivery catheter into the aorta via arterialaccess; and deploying the stent graft into the aorta.
 20. The method ofclaim 19, further comprising: introducing a second guidewire into theaorta via arterial access; loading a second delivery catheter containingan extender stent graft onto the second guidewire; moving the seconddelivery catheter along the second guidewire and introducing the seconddelivery catheter into a leg or a lumen of the stent graft via arterialaccess; and deploying a proximal end of the extender stent graft intothe leg or the lumen of the stent graft.